Category: Medicine

Medicine

Organon drug for endometriosis falls short in mid-stage study

Dive Brief: Organon’s experimental treatment for endometriosis failed to improve pelvic pain for women in a Phase 2 study, leading

Medicine

Regeneron bispecific approved for myeloma; Concentra to buy IGM

Today, a brief rundown of news involving Regeneron Pharmaceuticals, IGM Biosciences and Catalio Capital, as well as updates from Roche,

Medicine

Sodium channel blockers for pain: New opportunities after Vertex’s ‘watershed’ moment

In the notoriously expensive business of drug development, SiteOne Therapeutics made do with little. The biotechnology startup formed in 2010,

Medicine

Atai and Beckley, set to merge, reveal study success for psychedelic drug

Dive Brief: Atai Life Sciences and Beckley Psytech are making plans to push the psychedelic drug mebufotenin into Phase 3

Medicine

Moderna flu shot outperforms marketed vaccines in large late-stage trial

Dive Brief: Moderna’s seasonal influenza vaccine met its main goal in a large Phase 3 trial, reducing the risk of

Medicine

Sage to lay off most staff amid Supernus buyout

Dive Brief: Sage Therapeutics will lay off 338 employees, the vast majority of its workforce, while in the process of

Medicine

Incyte replaces CEO Hoppenot with dealmaker Meury

Dive Brief: Incyte has named veteran pharmaceutical executive Bill Meury as its new CEO, replacing longtime head Hervé Hoppenot, who

Medicine

Acadia’s ‘very bullish’ sales forecast restores some confidence on Wall Street

Acadia Pharmaceuticals has proposed that its pipeline of experimental medicines could, if eventually brought to market, peak at $12 billion

Medicine

Congress should reconsider breaking up PBMs, experts say

Bipartisan policies in Congress meant to lower drug costs by targeting middlemen in the pharmaceutical supply chain are likely to

Medicine

Supreme Court upholds ACA preventive services mandate

The Supreme Court on Friday upheld a popular provision of the Affordable Care Act that requires private insurers cover a range

Medicine

Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules

Today, a brief rundown of news involving Biocryst and Peter Marks, as well as updates from UCB and Altimmune that

Medicine

FDA takes major step to ease access to CAR-T therapy

Dive Brief: The Food and Drug Administration is easing limitations it imposed around the complex cancer drugs known as CAR-T therapies,

Medicine

Vor, with new CEO, changes course to target autoimmune disease

Dive Brief: Vor Biopharma is licensing rights to an immune disease drug from Chinese biotechnology company RemeGen, it said Wednesday,

Medicine

RFK Jr.-appointed panel recommends flu shots be free of contested preservative

Dive Brief: Advisers to the Centers for Disease Control and Prevention recommended Thursday that influenza vaccines used in the coming

Medicine

CDC panel, newly remade by RFK Jr., questions vaccine evidence

Robert F. Kennedy Jr.’s newly hand-picked panel of federal vaccine advisers met for the first time Wednesday since the Health

Medicine

Kymera adds Gilead as research partner, while advancing new candidate with Sanofi

Dive Brief: Kymera Therapeutics and Gilead Sciences will develop oral molecular glue degraders under a deal announced Wednesday, which could

Medicine

FDA investigating Elevidys safety; Nektar shares spike on eczema data

Today, a brief rundown of news involving Sarepta Therapeutics, Capricor Therapeutics and Nektar Therapeutics, as well as updates from AstraZeneca,

Medicine

Lexeo to help launch spinout around RNA drugs for the heart

Dive Brief: Perceptive Xontogeny Venture Funds and venBio Partners are contributing up to $40 million to a spinout of genetic

Medicine

Top drug official at FDA reportedly set to exit next month

Dive Brief: A top Food and Drug Administration official responsible for overseeing drug reviews is reportedly retiring from the agency,

Medicine

Relentless innovation: Bold exploration in advancing therapeutic options for every patient, every discovery

On the heels of the BIO International Convention and as I reflect on the passion for innovation that drives this

Medicine

A startup banks $66M to pursue ‘inclusive precision medicine’

Dive Brief: Actio Biosciences, a San Diego-based biotechnology startup, announced Wednesday it raised a $66 million Series B financing to

Medicine

Gene therapy faces fresh uncertainty as two more top FDA officials depart

Dive Brief: Two senior officials at the Food and Drug Administration office that regulates gene therapies have reportedly been placed

Medicine

A longer ‘winter’: Public funding slowdown heightens pressure on biotech startups

Biotechnology industry watchers were hopeful at the start of 2025. Venture funding appeared to be rebounding after a lengthy slump,

Medicine

Prothena to lay off majority of staff; Zealand shares obesity drug data

Today, a brief rundown of news involving Prothena and Zealand Pharma, as well as updates from Biogen and Sanofi that

Medicine

FDA to speed reviews for drugs supporting ‘national interests’

Food and Drug Administration Commissioner Martin Makary has proposed a dramatic expansion of the agency’s powers to speed up drug

Medicine

Draig, a brain drug startup, debuts with $140M to treat depression

Psychiatric medicine remains one of the more challenging and risky areas of drug research. Many prospects show initial promise only

Medicine

Scholar Rock drug preserves muscle in obesity trial

Dive Brief: A medicine developed to treat a genetic muscle-wasting disease can improve results for patients taking GLP-1 weight-loss medicines,

Medicine

FDA approves twice-yearly shot of Gilead drug for HIV prevention

The Food and Drug Administration has approved a new way to prevent HIV, clearing a Gilead Sciences drug that requires

Medicine

FDA clears CSL’s swelling disease drug; Regeneron loses 23andMe auction

Today, a brief rundown of news involving CSL and Intellia Therapeutics, as well as updates from Eli Lilly and 23andme

Medicine

Lilly to acquire Verve in $1B bet on gene editing for heart disease

Dive Brief: Eli Lilly agreed to buy Verve Therapeutics for $1 billion, betting on the promise of one-and-done gene therapies

Medicine

Roche, waving off study failures, commits to Phase 3 trials for Parkinson’s drug

Dive Brief: Roche will advance an experimental Parkinson’s disease drug with a mixed track record into late-stage development, announcing Monday

Medicine

Could the FDA take an indirect approach to regulate lab developed tests?

When the deadline to appeal the court decision that blocked the Food and Drug Administration’s final rule regulating laboratory developed

Medicine

FDA clears Nuvation lung cancer drug, setting up battle with Bristol Myers and Roche

Dive Brief: The Food and Drug Administration has approved a new oral medication for an uncommon kind of tumor, clearing

Medicine

Insmed surges on lung drug data; Recursion cuts staff

Today, a brief rundown of news involving Insmed and Recursion Pharmaceuticals, as well as updates from Odyssey Therapeutics, Gilead Sciences

Medicine

Pharma’s wins and losses in the budget bill

The budget bill currently under consideration in Congress is big — and it’s complicated. The 1,000-plus page document is full

Medicine

AstraZeneca forms an AI deal in China; Third Harmonic advances liquidation plans

Listen to the article 4 min This audio is auto-generated. Please let us know if you have feedback. Today, a

Medicine

Moderna wins FDA OK to widen use of RSV vaccine

The Food and Drug Administration has approved wider use of Moderna’s respiratory syncytial virus vaccine in a boost for a

Medicine

Novo, searching for a spark, plans late-stage trials for amylin drug

Dive Brief: Novo Nordisk is planning Phase 3 clinical trials for a obesity drug combination called amycretin, adding another emerging

Medicine

RFK Jr. reveals picks for influential vaccine panel

Health and Human Services Secretary Robert F. Kennedy Jr. on Wednesday continued his efforts to alter the government structure supporting

Medicine

BioNTech buys mRNA, courtroom rival CureVac in all-stock deal

Dive Brief: COVID vaccine maker BioNTech is buying rival CureVac, announcing Thursday an all-stock deal weeks before the two companies were

Medicine

Bristol Myers bolsters radiopharma portfolio with PhiloChem deal

Dive Brief: Bristol Myers agreed to pay $350 million up front to Philochem for worldwide rights to an experimental radiopharmaceutical

Medicine

SpliceBio lands $135M for a new kind of eye gene therapy

SpliceBio, a Spanish biotechnology company working on next-generation gene therapies, said Wednesday it raised $135 million in a Series B

Medicine

Vaccine makers face fresh uncertainty after firing of CDC panel

Dive Brief: Health and Human Services secretary Robert F. Kennedy Jr., has abruptly fired all members of the committee guiding

Medicine

Scorpion, fresh off Lilly deal, spins out startup Antares

Fresh off a multibillion-dollar deal with Eli Lilly, cancer drug startup Scorpion Therapeutics is trying for an encore, debuting a

Medicine

Merck antibody drug for RSV approved by FDA

The Food and Drug Administration has cleared a new treatment designed to protect infants from respiratory syncytial virus. Called Enflonsia

Medicine

Metsera shares climb on early data for amylin-targeting obesity shot

Dive Brief: An experimental weight loss drug developed by Metsera helped people with obesity lose up to 8% of their

Medicine

Regeneron makes obesity push; Atai, Alto ink brain drug deals

Today, a brief rundown of news involving Regeneron and Bluebird bio, as well as updates from Atai Life Sciences, Alto

Medicine

Lilly partners with Camurus in search of a long-lasting obesity drug

Dive Brief: Looking to defend its giant cardiometabolic health franchise, Eli Lilly is licensing a technology from Swedish biotechnology firm

Medicine

Bispecific cancer drugs, data caveats and funding alarms: 3 takeaways from ASCO

New drugs, however heralded, take time to embed into clinical care. Enhertu, the powerful antibody-drug conjugate from Daiichi Sankyo and

Medicine

FDA’s AI tool ‘Elsa’ is here, and the industry has questions

The Food and Drug Administration aims to roll out its new AI tool, called Elsa, “ahead of schedule and under

Medicine

Otsuka tops Vera with kidney drug data; Regenxbio sinks on Duchenne update

Today, a brief rundown of news involving Otsuka Pharmaceutical and Arvinas, as well as updates from Regenxbio, Vigil Neuroscience and

Medicine

FDA meeting gives window into gene therapy field’s angst

Anyone looking for evidence of genetic medicine’s enormous promise need only read of KJ Muldoon. The 10-month-old infant headed home

Medicine

Daiichi Sankyo struck gold with ‘ADC’ cancer drugs. Its new CEO has to figure out what’s next.

CHICAGO — Hiroyuki Okuzawa holds an enviable position. The veteran Daiichi Sankyo executive took over as the Japanese drugmaker’s new

Medicine

Cullinan doubles down on bispecifics for autoimmune disease with Genrix deal

Dive Brief: After changing its name and focus, Cullinan Therapeutics is beefing up its autoimmune disease pipeline by licensing an

Medicine

FDA to use new review tool on Sarepta’s gene therapy work

Dive Brief: The Food and Drug Administration has awarded Sarepta Therapeutics a new kind of fast pass that could help

Medicine

Biotech funding plummets as Trump policies unnerve investors: Jefferies

The amount of funding going into biotechnology companies has fallen off over the last couple months, a trend the investment

Medicine

J&J data support earlier use of combo pill in prostate cancer

CHICAGO — A Johnson & Johnson drug currently used for advanced prostate cancer can help keep the disease from progressing in

Medicine

Bayer drug could ease side effects of common breast cancer treatment, detailed data show

An experimental, non-hormonal drug from Bayer can reduce the hot flashes and other menopausal side effects many women taking a

Medicine

Kymera, with new data, takes early step toward a Dupixent-like pill

Dive Brief: An experimental protein-degrading drug from Kymera Therapeutics appeared safe and able to affect its intended target in an

Medicine

Bispecific competition, debating oral SERDs and a bold GLP-1 prediction

CHICAGO — The American Society of Clinical Oncology’s annual meeting is a forum for data. On Monday, it was also

Medicine

AstraZeneca drug could help keep a common breast cancer at bay

CHICAGO — Too often, cancer has a way of evading treatment. Tumors that were held in check begin to spread

Medicine

A funding flashpoint, Pfizer’s $1B poster and AstraZeneca advertising

Funding cancer research isn’t usually a political flashpoint. But as the Trump administration signals its desire to drastically cut the

Medicine

FDA clears Moderna’s new COVID vaccine, but with limits

The Food and Drug Administration has granted an approval to Moderna’s next-generation COVID-19 vaccine, but with limits that will restrict

Medicine

At ASCO, Enhertu cements growing role in stomach cancer care

AstraZeneca and Daiichi Sankyo’s targeted cancer medicine Enhertu helped participants in a late-stage clinical trial with a type of advanced

Medicine

Keros lays off nearly half its staff; Astellas buys into a China biotech’s ADC

Today, a brief rundown of news involving Astellas Pharma and Keros Therapeutics, as well as updates from Stealth Biotherapeutics, PepGen

Medicine

New Summit data could slow US approval plans for PD-1/VEGF drug

Dive Brief: A dual-acting drug developed by Summit Therapeutics and Akeso delayed tumor progression in a Phase 3 lung cancer

Medicine

Intellia filing spurs safety concerns over CRISPR drug

Dive Brief: Intellia Therapeutics shares dropped 25% early Thursday after the gene-editing company disclosed that one patient in an ongoing

Medicine

HHS terminates Moderna contract to develop bird flu vaccine

The U.S. The Department of Health and Human Services has canceled a contract with Moderna to develop messenger RNA vaccines

Medicine

Muscle-sparing obesity drug safe for Phase 3 trial, Veru says

Dive Brief: Veru’s muscle-preserving obesity drug enobosarm, when combined with Novo Nordisk’s Wegovy, may have less gastrointestinal side effects at

Medicine

Cancer drugmaker iTeos to shut down

Dive Brief: Cancer drugmaker iTeos Therapeutics said Wednesday it plans to wind down operations and seek to sell the company’s

Medicine

Lilly to buy pain drug developer SiteOne, challenging Vertex

Eli Lilly is wagering up to $1 billion on a private biotechnology company developing new, non-opioid pain drugs that have

Medicine

FDA sets COVID vaccine formula as RFK Jr. narrows guidance for shots

Dive Brief: The Food and Drug Administration on Thursday recommended COVID-19 vaccine manufacturers tailor their shots for the upcoming fall and

Medicine

FDA panel backs Darzalex for early stage multiple myeloma

Expert advisers to the Food and Drug Administration on Tuesday backed Johnson & Johnson’s Darzalex for people with an asymptomatic

Medicine

FDA advisers pan Pfizer’s PARP drug; Sarepta to resume Duchenne study

Today, a brief rundown of news involving Pfizer and Sarepta Therapeutics, as well as updates from UroGen Pharma, Altos Labs

Medicine

Novo pressures GLP-1 compounders as FDA ban takes hold

Novo Nordisk is ramping up its war on compounders making versions of its top-selling semaglutide medicine as the regulatory grace

Medicine

House passes reconciliation bill with massive Medicaid cuts

The House passed Republicans’ “big, beautiful bill” on Thursday in a razor-thin 215-214 vote, sending the legislation — which includes the most

Medicine

AI tool could help doctors ID breast cancers vulnerable to Enhertu

For decades now, doctors tasked with diagnosing breast cancer have peered into microscopes and pored over slides, hunting for signs

Medicine

Zepzelca, Tecentriq combo extends survival in hard-to-treat lung cancer

A combination of Roche’s cancer immunotherapy Tecentriq and a drug called Zepzelca helped extend survival in people with a hard-to-treat

Medicine

FDA panel recommends keeping COVID shots targeted to same strain as last year

Advisers to the Food and Drug Administration have recommended COVID-19 vaccine makers continue to target their shots to the so-called

Medicine

Sanofi gains experimental Alzheimer’s drug through Vigil buyout

Sanofi has agreed to spend $470 million to take control of a young biotechnology company and its experimental drug for

Medicine

Reproductive health startup raises $65M for infertility drugs

ReproNovo, a biotechnology company specializing in reproductive medicine, has raised $65 million to advance two drugs it thinks could help

Medicine

Moderna pulls application for combo COVID, flu shot

Dive Brief: After discussions with the Food and Drug Administration, Moderna on Wednesday said it has voluntarily withdrawn its application

Medicine

FDA sets stricter approval standards for COVID vaccines

The Food and Drug Administration is changing how it reviews new COVID-19 vaccines, setting out stricter standards in place of

Medicine

Tourmaline shares fall on Phase 2 data; Schrödinger cuts staff

Today, a brief rundown of news involving Tourmaline Bio, Schrödinger and Beckley Psytech, as well as updates from CRISPR Therapeutics

Medicine

Prime Medicine claims ‘proof of concept,’ but lays off staff in pivot

Prime Medicine will lay off one-quarter of its workforce and deprioritize its clinical-stage program for a rare genetic disease as

Medicine

Regeneron wins bid to buy 23andMe out of bankruptcy

Regeneron Pharmaceuticals, a biotechnology company with a long history of large-scale genetics research, plans to buy DNA testing firm 23andMe

Medicine

Stopping a ‘moral obscenity’: Senate Judiciary Committee expresses support for PBM reform

There’s still significant support in Congress for overhauling the pharmacy benefit manager industry, after reforms almost made it across the

Medicine

AbbVie stakes $335M on a startup’s RNAi drugs

AbbVie is staking hundreds of millions of dollars on RNA interference, agreeing on Wednesday to work with biotechnology startup ADARx

Medicine

FDA delays approval decision for Biohaven rare disease drug

Connecticut-based Biohaven has been developing what it hopes will be the first medicine for a group of rare, nerve-destroying diseases.

Medicine

Novo CEO to depart as obesity drugmaker’s challenges rise

Novo Nordisk CEO Lars Fruergaard Jørgensen, who led the Danish drugmaker to new heights through its development of powerful medicines

Medicine

BioMarin to buy rare disease drugmaker Inozyme for $270M

BioMarin Pharmaceutical has agreed to spend $270 million to take control of a Boston-based drug company with complementary expertise in

Medicine

Regeneron defeats Amgen in PCSK9 case; 2 cell therapy biotechs cut staff

Today, a brief rundown of news involving Amgen and Regeneron, as well as updates from Travere Therapeutics, Allogene and Kyverna

Medicine

A bespoke CRISPR therapy suggests a blueprint for treating ‘N-of-1’ diseases

A group of scientists successfully made a bespoke gene editing medicine for a critically ill baby in just a few

Medicine

Sanofi to pour more than $20B into US drug research and manufacturing

Dive Brief: Sanofi plans to invest at least $20 billion in the U.S. over the next five years as the

Medicine

Novo to work with Septerna in hunt for oral obesity drugs

Dive Brief: Novo Nordisk on Wednesday said it will collaborate with biotechnology startup Septerna to hunt new obesity drug prospects,

Medicine

5 questions on Trump’s plan to lower US drug prices

President Donald Trump’s declaration Monday that the Department of Health and Human Services will pursue a plan to “equalize” drug

Medicine

Women’s health faces growing headwinds, despite jump in venture investment

The women’s health field has a long way to go addressing persistent deficits in research and treatment. Common conditions that

Medicine

iTeos, GSK to shelve TIGIT drug after study setback

Dive Brief: A two-drug regimen involving an experimental cancer immunotherapy from iTeos Therapeutics and GSK didn’t significantly delay tumor progression

Medicine

FDA follows EMA in limiting use of Valneva shot

Safety concerns have spurred the Food and Drug Administration and Centers for Disease Control and Prevention to recommend suspending use

Medicine

Trump revives ‘most favored nation’ plan in effort to cut US drug prices

The Trump administration is resurrecting a controversial policy that aims to tamp down some pharmaceutical costs in the U.S. by

Medicine

[Podcast] Behind the Breakthroughs: How Almac Powers Clinical Trial Success with Care

Emerging biopharma companies are now taking the lead on drug development, with smaller and more agile firms able to meet

Medicine

Novo cuts forecasts as compounded GLP-1s weigh on sales

Dive Brief: While revenue and profit rose year-over-year during the first quarter at Novo Nordisk, the Danish drugmaker on Wednesday

Medicine

Haya banks $65M to scour the ‘dark genome’ for new drugs

Scientists long believed the human genome consisted mostly of useless DNA. These sequences, after all, aren’t translated into proteins, making

Medicine

Gilead, bracing for tariffs, joins peers in US drug production push

Dive Brief: Gilead on Wednesday became the latest U.S. drugmaker to pledge new investments in U.S. manufacturing, as President Trump

Medicine

Eli Lilly extends Purdue alliance; EMA investigates Valneva shot

Today, a brief rundown of news involving Eli Lilly and Valneva, as well as updates from CRISPR Therapeutics, Vivo Capital

Medicine

Viatris’ new form of old pain drug scores in large trials

Pittsburgh-based pharmaceutical firm Viatris on Thursday said a pain drug it’s been developing succeeded in two large clinical trials, setting

Medicine

4 more biotechs cut staff amid market tumult

Four biotechnology companies are laying off staff in the latest examples of cutbacks in a sector struggling to hold its

Medicine

Biotech is guessing how Vinay Prasad might change the FDA. His research, writing offer clues.

To hear Vinay Prasad tell it, U.S. healthcare is too ready to intervene unnecessarily, use prescription drugs without sufficient evidence

Medicine

FDA set to meet this month on COVID vaccines

A panel of Food and Drug Adminsitration advisers will meet May 22 to discuss updating the formula of COVID-19 vaccines

Medicine

Vinay Prasad, a physician and FDA critic, to lead agency center overseeing vaccines

Vinay Prasad, a prolific academic and longtime critic of U.S. drug policies, was named Wednesday as the new leader of

Medicine

Prasad’s FDA appointment pressures cell and gene therapy stocks

Shares in more than a dozen gene and cell therapy developers tumbled by double digits Wednesday after a well-known critic

Medicine

AI specialist Recursion trims pipeline in latest shakeup

AI drug discovery specialist Recursion Pharmaceuticals is shelving three of its most advanced drug prospects in an effort to cut

Medicine

PTC stock slides on new data for Huntington’s drug

Dive Brief: Shares in PTC Therapeutics fell by double-digits Monday morning as investors parsed new clinical trial results for an

Medicine

Madrigal’s MASH drug sales again top Wall Street projections

Dive Brief: Madrigal Pharmaceuticals said its pioneering medicine for a common liver disease brought in $137.3 million in the first

Medicine

AstraZeneca quietly exits neuroscience | BioPharma Dive

AstraZeneca on Tuesday confirmed it has closed down its neuroscience research group to direct resources toward more “high value” projects.

Medicine

Arvinas, Entrada cut staff; Merck builds US hub for Keytruda

Today, a brief rundown of news involving Arvinas and Biogen, as well as updates from Merck & Co., Entrada Therapeutics

Medicine

CVS strikes Wegovy deal with Novo Nordisk

Dive Brief: CVS Health’s pharmacy benefit manager Caremark reached an agreement with Danish drugmaker Novo Nordisk to give its weight

Medicine

Cytokinetics reveals unexpected delay; AstraZeneca combo therapy hits in asthma

Today, a brief rundown of news involving Cytokinetics and AstraZeneca, as well as updates from Repare Therapeutics, Amicus Therapeutics and

Medicine

Amgen’s Stelara biosimilar gets off to fast start

Dive Brief: Amgen on Thursday said its just-launched biosimilar of Johnson & Johnson’s autoimmune drug Stelara recorded $150 million in

Medicine

Pharma downplays tariff threat, even as risks remains unclear

The threat of tariffs on pharmaceuticals imported to the U.S. hasn’t yet pushed drugmakers off course, with many of the

Medicine

Moderna combination flu, COVID shot delayed amid FDA scrutiny

The Food and Drug Administration has asked Moderna for additional data before it will consider approving a combination shot the

Medicine

Siren, a gene therapy startup, tests unconventional alternative to venture funding

Biotechnology startups usually turn to a few tried-and-true options to raise the money they need to develop a new drug.

Medicine

Novartis to acquire Regulus in deal for kidney disease drug

Novartis will pay $800 million upfront to acquire Regulus Therapeutics, a San Diego biotechnology company that launched nearly two decades

Medicine

Pfizer’s Bourla ‘cautiously optimistic’ on looming US pharma tariffs

Pfizer will maintain its 2025 financial forecasts for now, but warned Tuesday it can’t predict the impact of any tariffs

Medicine

Acelyrin should liquidate instead of merging with Alumis, investor says

A shareholder of immune drug developer Acelyin believes the company is better off shutting down and returning cash to shareholders

Medicine

Merck KGaA to buy biotech SpringWorks for $3.9B

Dive Brief: Merck KGaA has agreed to buy biotechnology company SpringWorks Therapeutics, announcing Monday a $3.9 billion deal after months

Medicine

Novavax says vaccine application still ‘approvable,’ despite FDA delay

Novavax claims it can surmount the latest regulatory hurdle hindering its quest to win full U.S. clearance of its COVID-19

Medicine

How integrated real-world data helps identify and improve outcomes for rare disease patients

Rare diseases pose a significant challenge for healthcare systems, patients and pharmaceutical companies alike. The journey from symptom onset to

Medicine

Sanofi stays on course amid tariff turmoil

Dive Brief: Sanofi’s first-quarter sales and profit exceeded analyst expectations, but the company held tight on its full-year guidance amid

Medicine

Caribou, in reversal, scraps autoimmune cell therapy and cuts staff

Caribou Biosciences is laying off about a third of its staff and stopping work on an experimental lupus treatment in

Medicine

Halozyme sues Merck; FDA blames cuts for Vanda delay

Today, a brief rundown of news involving Merck and Vanda Pharmaceuticals, as well as updates from Sanofi and Novo Holdings

Medicine

Gilead leans on HIV drugs as oncology sales slow

Dive Brief: Gilead Sciences on Thursday reported $6.7 billion in revenue in the first quarter, missing consensus Wall Street estimates

Medicine

Biohaven stock slides on withdrawal of European marketing application

Biohaven lost close to $400 million in market value Friday on news that the Connecticut-based drug developer had withdrawn an

Medicine

Merck takes $200M tariff hit, trimming its gross profits

Dive Brief: Merck & Co. “absorbed” $200 million in addition expenses related to U.S. and overseas tariffs in the first

Medicine

Bristol Myers says schizophrenia drug launch ‘off to a solid start’

A new, closely watched schizophrenia medication from Bristol Myers Squibb sold well in its first full quarter on the market,

Medicine

Etiome, a new Flagship startup, looks to catch disease before it strikes

Flagship Pioneering unveiled its latest biotechnology startup on Thursday, a company aiming to map the progression of diseases and tailor

Medicine

German antibody maker valued at $1.6B in blank-check merger

Dive Brief: Veraxa Biotech, a cancer therapy developer backed by Swiss incubator Xlife Sciences, will go public through a combination

Medicine

Roche looks to a Flagship startup in search of new immune drugs

Repertoire Immune Medicines has formed its second pharmaceutical partnership since changing course a few years ago, announcing Wednesday a new

Medicine

Roche, answering tariff threat, pledges $50B to US drug production

Dive Brief: Roche is the latest drugmaking planning to expand drug production in the U.S., announcing Tuesday a pledge to

Medicine

The Trump administration is remaking HHS. Track the changes here.

The Trump administration is radically revising the scale and scope of the federal health workforce. Approximately 1 in 4 employees

Medicine

Novo says it’s submitted obesity pill for FDA approval

Dive Brief: Novo Nordisk asked the Food and Drug Administration to approve a pill version of its popular weight loss

Medicine

A judge blocked the FDA’s plan to regulate lab developed tests. What now?

The Food and Drug Administration’s attempt to increase regulatory scrutiny over laboratory developed tests appears to be dead, much to

Medicine

FDA cuts outlined in draft HHS budget

A draft budget document shows the Trump administration’s plan to slash funding to the Department of Health and Human Services

Medicine

GSK prepares to relaunch Blenrep; Activists challenge another ‘zombie’ biotech

Today, a brief rundown of news involving GSK and Bristol Myers Squibb, as well as updates from Elevation Oncology, Bayer

Medicine

Makary seeks to limit industry’s role in FDA advisory panels

The Food and Drug Administration will aim to limit the participation of industry experts in the advisory committees that the

Medicine

Sanofi, Regeneron win FDA nod for Dupixent in chronic hives

The Food and Drug Administration on Friday approved a new use for Sanofi and Regeneron’s top-selling immune disease drug Dupixent,

Medicine

An investment fund sets out to free biotech’s ‘trapped capital’

A British investment fund has launched with plans to extract tens of billions of dollars it believes to be “trapped”

Medicine

Sanofi licenses immune disease drugs from startup Earendil

Dive Brief: French drugmaker Sanofi agreed to pay $125 million to startup Earendil Labs for two drug candidates designed to

Medicine

Lilly’s obesity pill scores in large diabetes trial

Dive Brief: Eli Lilly’s weight loss pill orforglipron succeeded in a Phase 3 clinical trial in diabetes, helping study participants

Medicine

New research kindles excitement around stem cell therapies for Parkinson’s

The most effective drug for Parkinson’s disease hasn’t changed in 50 years. But fresh research published in one of the

Medicine

Bluebird says Ayrmid missed deadline for rival takeover bid

Bluebird bio is still waiting on a binding takeover bid from Ayrmid Ltd., three weeks after the company said it

Medicine

Startup Glycomine raises $115M to push rare disease drug deeper into testing

Glycomine, a biotechnology startup working on a treatment for a rare genetic disorder, has raised a $115 million Series C

Medicine

J&J keeps forecasts steady as pharma confronts tariff threat

Johnson & Johnson is confident it can manage the impact of tariffs on its pharmaceuticals and medical device businesses this

Medicine

Safety worries spur Pfizer to drop another obesity pill

Dive Brief: Pfizer is scrapping another obesity pill, announcing Monday it will stop testing an experimental therapy called danuglipron after

Medicine

US launches probe that could set stage for pharma tariffs

The Trump administration is investigating the effects of pharmaceutical imports on national security, disclosing Monday a probe that is likely

Medicine

Mining the hidden gems in unstructured EMR data

Pharma companies are increasingly turning to real-world data to answer their commercial business questions, but not all realize that unstructured

Medicine

Medtech industry pressures White House to exempt devices from tariffs

AdvaMed and nine other healthcare organizations continue to pressure the White House to exempt medical devices and critical supplies from

Medicine

Trump says ‘major’ tariffs coming on pharmaceuticals

Dive Brief: President Trump on Tuesday said he’s planning soon to announce “a major tariff on pharmaceuticals,” which were exempted

Medicine

Tempest seeks strategic alternatives as cash runs out for Phase 3 trial

Dive Brief: Tempest Therapeutics is seeking a buyer or partner, saying Wednesday it has hired financial advisers to “advance its

Medicine

FDA plans to phase out animal testing for some drugs

Dive Brief: The Food and Drug Administration aims to phase out animal toxicology testing for experimental drugs, announcing Thursday a

Medicine

Amgen says Imdelltra extended survival; Parker Institute adds new leaders

Today, a brief rundown of news involving Amgen and the Parker Institute, as well as updates from J&J, Alzheon and

Medicine

Biotech CEOs, VCs urge Cassidy, Senate to ease impact of FDA cuts

Dive Brief: Biotech executives and venture capital investors are banding together to press Congress to act on Food and Drug

Medicine

Amid tariff turmoil, Novartis commits to spending $23B on U.S. manufacturing

Dive Brief: Novartis will substantially expand its U.S. footprint, announcing Thursday plans to spend $23 billion over five years to

Medicine

Ferring gene therapy sales grow; ASH calls for restoration of cut CDC division

Today, a brief rundown of news involving Ferring Pharmaceuticals and Solu Therapeutics, as well as updates from the American Society

Medicine

Trump pauses most reciprocal tariffs, hikes China’s further

The U.S. is pausing most country-specific tariffs for 90 days while raising duties on imports from China to 125%, President

Medicine

Rallybio discontinues lead drug for rare maternal disorder

Dive Brief: The biotechnology company Rallybio is discontinuing its lead candidate for a rare blood disorder in pregnant women after

Medicine

US risks losing biotech edge to China, report warns

The U.S. risks losing a once-decisive edge over China in biotechnology unless the federal government prioritizes the sector’s advancement with

Medicine

Tango Therapeutics cuts nearly one-fifth of staff

Oncology drugmaker Tango Therapeutics has cut about 20% of its staff, following a year in which it twice trimmed its

Medicine

Judge permanently blocks Trump admin plan to cap NIH funding, setting up appeals battle

Dive Brief: Research universities won an extended reprieve Friday when a federal judge permanently barred the National Institutes of Health

Medicine

New genetic medicine CDMO acquires Landmark Bio

Dive Brief: Artis BioSolutions emerged from stealth Wednesday, announcing that it has acquired Landmark Bio, an alliance of academic institutions,

Medicine

Biotech ‘megarounds’ hold steady as startups, VCs wait on IPOs

Biotechnology company funding rounds remain larger than they were in 2022 and 2023, in a sign venture firms continue to

Medicine

Oz confirmed by Senate to lead CMS

Mehmet Oz, a physician and TV personality, was confirmed Thursday by the U.S. Senate to lead the Centers for Medicare

Medicine

M&A recap: Big pharma starts the year mostly avoiding billion-dollar deals

The world’s largest pharmaceutical companies mostly steered clear of billion-dollar acquisitions in the early months of this year, perhaps indicating

Medicine

Trial monitors recommend Elevidys studies continue; Novartis kidney drug approved

Today, a brief rundown of news involving Sarepta Therapeutics, Novartis and Allakos, as well as updates from CSL Behring and

Medicine

Tariffs send healthcare industry into ‘unchartered waters’

Healthcare industry groups and analysts are reeling after President Donald Trump unveiled a sweeping tariff policy Wednesday that could impact

Medicine

FDA misses approval deadline for Novavax’s COVID-19 vaccine

The Food and Drug Administration review deadline for Novavax’s COVID-19 vaccine has come and gone without a decision amid a

Medicine

Roche halts testing of Sarepta Duchenne gene therapy in Europe

Dive Brief: Roche has stopped enrolling and treating patients in three studies of the gene therapy Elevidys following the death

Medicine

Trump installs sweeping new tariffs, but pharma appears to dodge blow

The U.S. will implement a universal baseline tariff of 10%, effective April 5, along with increased tariff rates on various

Medicine

Leqembi’s EU review drags on; Sanofi gets a new development head

Today, a brief rundown of news involving Eisai, Biogen and Sanofi, as well as updates from Opthea, Novartis, and PTC

Medicine

Judge overturns FDA’s lab developed test regulation, siding with industry

A Texas federal court on Monday struck down the Food and Drug Administration’s new rule regulating laboratory developed tests as

Medicine

HHS begins layoffs in chaotic fashion

Employees across the Department of Health and Human Services began receiving layoff notices Tuesday, following days of anxious waiting to

Medicine

Isomorphic raises $600M on big ambitions for AI drugmaking tech

Isomorphic Labs, a British company developing new ways to design and develop medicines, said Monday it raised $600 million to

Medicine

Cell, gene therapy makers lose a champion at FDA with exit of Peter Marks

Over the past decade, several dozen cell and gene therapies have reached market in the U.S., bringing with them the

Medicine

How discoverable, comparable and explorable is your data?

If you’re a discovery scientist, you’re probably familiar with the fierce competition that dominates the landscape of biomarker identification. As

Medicine

‘Everything is word of mouth’: HHS employees face uncertainty in looming Trump layoffs

Just before 9 a.m. Thursday in Washington, D.C, the Department of Health and Human Services sent out a press release

Medicine

FDA broadens use of Novartis’ radiopharma drug Pluvicto

Dive Brief: Novartis’ radiopharmaceutical drug Pluvicto can now be used much more widely to treat men with a type of

Medicine

Peter Marks, FDA’s top vaccine official, resigns

Peter Marks, the Food and Drug Administration’s top vaccine official, abruptly resigned from the agency on Friday, citing disagreement with

Medicine

Bluebird gets rival takeout offer from Ayrmid

Bluebird bio on Friday received a new buyout offer that surpasses a take-private bid the pioneering gene therapy developer received

Medicine

FDA approves first-of-its-kind RNA drug for hemophilia

The Food and Drug Administration approved on Friday a new type of medicine for people with the rare bleeding disorder

Medicine

Alcon buys majority stake in IPO-seeking cell therapy startup Aurion

The leading eye-care company Alcon on Wednesday said it has acquired a majority stake in Aurion Biotech, capping months of

Medicine

Nkarta to lay off staff, senior leadership, in bid to advance autoimmune cell therapy

Nkarta is laying off a third of its workforce, and more than half its executive team, in a bid to

Medicine

Makary confirmed by Senate as FDA commissioner

The U.S. Senate on Tuesday confirmed Johns Hopkins University surgeon Martin Makary to be commissioner of the Food and Drug

Medicine

First Prader-Willi drug to reduce hunger approved by FDA

The Food and Drug Administration on Wednesday approved the first treatment for the insatiable hunger associated with the rare disease

Medicine

Character Biosciences raises $93M with an eye on vision loss drugs

Character Biosciences, a biotechnology startup developing treatments for vision loss, said Tuesday it raised $93 million in a Series B

Medicine

Merck bets $200M on a new type of heart pill

Dive Brief: Merck & Co. has entered a competitive race for a new type of heart drug, announcing Tuesday it

Medicine

23andMe files for bankruptcy as CEO Anne Wojcicki resigns

Dive Brief: 23andMe, the DNA testing company once valued at $6 billion, filed for Chapter 11 bankruptcy protection on Sunday

Medicine

Verve gets FDA green light to expand base editing trial into US

Verve Therapeutics is expanding a gene editing trial for a cholesterol and heart disease treatment into the U.S., the company

Medicine

Leveraging clinical and financial data sets to guide investment strategies in 2025’s biopharma market

To say global markets have been choppy in 2025 is an understatement. Unsurprisingly, biopharma remains one of the most dynamic

Medicine

J&J boosts US manufacturing as big pharma reshores

Dive Brief: Johnson & Johnson is planning a major U.S. expansion, announcing Friday it will spend $55 billion over the

Medicine

Alnylam prices heart drug at premium to rivals

Alynlam Pharmaceuticals will sell its drug for a life-threatening heart disease at almost double the cost of other treatments available