Medicine

Eli Lilly will give small biotechnology companies a chance to use artificial intelligence models trained on years of the pharmaceutical company’s research, launching Tuesday a new platform its says could…

Dive Brief: Novartis on Tuesday said it will pay $1.4 billion to acquire the New York-based biotechnology company Tourmaline Bio and its experimental cardiovascular disease drug. Per deal terms, the…

Dive Brief: BioNTech’s experimental bispecific cancer drug pumitamig helped shrink tumors in three-quarters of people with small cell lung cancer who were enrolled in a Phase 2 trial, and stabilized…

Dive Brief: Pfizer and partner BioNTech said Monday their updated COVID-19 booster spurred strong immune responses against currently circulating coronavirus strains in late-stage testing, adding a key piece of evidence…

Dive Brief: Enveda Biosciences said Thursday it raised $150 million in Series D financing, doubling the cash it’s pulled in from venture capitalists this year to further its drug discovery.…

Dive Brief: Sanofi shares dropped after the French drugmaker reported results from a highly anticipated study of a new kind of medicine for eczema that disappointed analysts and investors.  The…

Dive Brief: The Food and Drug Administration plans to work more closely and flexibly with developers of drugs for certain ultra-rare conditions, outlining Wednesday a new process to coordinate its…

Prolific biotechnology investment firm Atlas Venture said Thursday it raised $400 million to pump into its existing portfolio of drug startups, a move meant to support the companies that might…

Today, a brief rundown of news involving the Food and Drug Administration and Gilead Sciences, as well as updates from AC Immune, Agios Pharmaceuticals, Merck KGaA that you may have…

A newly launched startup is the latest young company to build itself around a drug discovered in Chinese laboratories. Hengrui Pharma on Friday said it licensed an experimental heart medicine…

U.S. lawmakers clashed with Health and Human Services Secretary Robert F. Kennedy Jr. over his changes to the country’s vaccine policy and oversight of the Centers for Disease Control and…

For the past four years or so, veteran drug hunters Josh Bilenker and Jeff Engelman have kept tightly under wraps the details of their latest project, a biotechnology startup called…

Biohaven’s top executive said his team is well-prepared to sell a therapy that could be not only the first approved medicine for a group of rare brain diseases, but also…

Novartis is once again taking aim at Parkinson’s disease, through a deal with Arrowhead Pharmaceuticals that could be worth billions of dollars. The deal, announced Monday, revolves around a preclinical…

Today, we’re catching up after a long weekend on news involving Amgen and Replimune, as well as updates from Sanofi, Roche, Eisai and Biogen that you may have missed. Amgen…

Innovators don’t just focus on what’s in front of them; they look toward the future and imagine what could be. The 21st century has brought incredible scientific advances, inspiring us…

The case of Stealth BioTherapeutics and its rare disease drug could become a regulatory bellwether for other biotechnology companies seeking to understand how flexibly new leaders at the Food and…

Dive Brief: Wugen said Wednesday that it brought in $115 million in a new financing round that will help the company advance an “off-the-shelf” CAR-T therapy. Fidelity Management & Research…

Today, a brief rundown of news involving Amylyx Pharmaceuticals and Sanofi, as well as updates from Novartis, Roche and Eisai that you may have missed. A mid-stage clinical trial testing…

Dive Brief: Novo Nordisk is again looking for help outside its own laboratories as it works to build on the success of Ozempic and its sister medicine Wegovy. In the…

A federal vaccine panel recently remade by Health and Human Services Secretary Robert F. Kennedy Jr. will meet in September to discuss and potentially vote on recommendations for vaccines against…

Dive Brief: People with early breast cancer who were treated in a late-stage study with Eli Lilly’s drug Verzenio and standard hormone therapy lived longer than those given hormone therapy…

The Food and Drug Administration on Wednesday approved updated COVID-19 vaccines that target a commonly circulating coronavirus strain, but narrowed who in the U.S. can receive them. In a post…

Dive Brief: An RNA medicine developed by Regeneron Pharmaceuticals and Alnylam Pharmaceuticals helped control symptoms of the chronic autoimmune disease generalized myasthenia gravis in adults enrolled in a late-stage study,…

Dive Brief: Eli Lilly on Tuesday said it is ready to ask the Food and Drug Administration for approval of its GLP-1 pill orforglipron after the drug met the main…

The Food and Drug Administration has suspended the license of Valneva’s chikungunya vaccine following new reports of serious adverse reactions, sending shares in the French drugmaker sharply lower on Monday.…

Dive Brief: Royalty Pharma has grabbed rights to a share in revenue from lung cancer drug Imdelltra, announcing Monday it will pay $885 million upfront for BeOne Medicine’s royalties paid…

A much-anticipated report from the Make America Healthy Again Commission was postponed earlier this month. But nestled within leaked documents is a strategy that reveals more about health leaders’ goals,…

Dive Brief: Rocket Pharmaceuticals plans to restart a Phase 2 gene therapy trial for a rare heart disease after working with the Food and Drug Administration to resolve questions around…

The United States and the European Union formalized the terms of the framework trade agreement the two trading partners announced at the end of July, per a joint statement published…

Dive Brief: Sarepta on Thursday said it’s reached agreements that remove about $700 million from a pile of debt due in 2027. The private agreements with debt holders will allow…

Today, a brief rundown of news involving Biohaven and Catalent, as well as updates from Stealth Biotherapeutics, Jazz Pharmaceuticals and Celldex Therapeutics that you may have missed. The Food and…

Dive Brief: Gilead Sciences is deepening its investment in cancer cell therapy, announcing Thursday a deal to pay $350 million to buy privately held Interius BioTherapeutics for a technology designed…

The Food and Drug Administration on Thursday approved a drug Ionis Pharmaceuticals developed for the rare genetic disease hereditary angioedema, making the therapy, known as donidalorsen, the third new medicine…

Eli Lilly is searching for a new neuroscience chief after announcing Wednesday that the division’s current head, Anne White, will retire in December after a 30-year career at the Indianapolis…

Xoma Royalty Corp. is acquiring another struggling biotechnology company in further sign of interest among certain firms in buying floundering drugmakers and shutting them down. Xoma on Wednesday agreed to…

Dive Brief: Australian drugmaker CSL is separating its vaccine business, Seqirus, into a standalone company as part of a sweeping restructuring across its business that will involve workforce cuts of…

Dive Brief: An experimental weight loss pill from Viking Therapeutics helped people with obesity lose up to 12% of their body weight over 13 weeks in a Phase 2 trial,…

To many scientists and doctors, messenger RNA vaccines are an incredible feat of modern medicine. But to top health leaders in the Trump administration, shots made with the technology pose…

Dive Brief: Stealth BioTherapeutics is once again seeking U.S. approval of a drug for the rare condition Barth syndrome, claiming in an announcement Monday that it has addressed concerns that…

Over the next five years, several blockbuster oncology drugs from leading pharmaceutical companies will lose patent protection, ushering in a wave of “patent cliffs” that pose significant revenue and strategic…

The Trump administration recently added to an ongoing push to boost pharmaceutical manufacturing in the U.S., launching a new program dubbed PreCheck that aims to ease the process of bringing…

Vedanta Biosciences, a startup working on microbiome drug research for more than a decade, will lay off nearly a fifth of its staff after one of its top prospects failed…

Merck KGaA has been making moves to propel itself into becoming what CEO Belén Garijo described as a “globally diversified science and technology powerhouse.” Most recently, the company closed a…

Today, a brief rundown of news involving Precigen and Pfizer, as well as updates from the Institute for Clinical and Economic Review, Superluminal Medicines and Generation Bio that you may…

The Department of Health and Human Services announced Thursday it will reinstate a disbanded task force on childhood immunizations, claiming that it will work to improve the “safety, quality, and…

Dive Brief: Sarepta on Wednesday announced the divestment of its entire equity stake in partner Arrowhead Pharmaceuticals as the company faces the need to make milestone payments of as much…

Eli Lilly on Thursday responded to a Trump administration plan to lower U.S. drug costs by issuing a statement claiming it will raise prices in European countries to “align” them…

Dive Brief: Vor Biopharma on Wednesday said a late-stage study run in China by its partner RemeGen succeeded, showing that treatment with an experimental drug called telitacicept helped reduce disease…

AbbVie plans to spend $195 million to build a new facility to produce active pharmaceutical ingredients in its hometown of North Chicago, Illinois. Construction will begin in the fall, and…

Dive Brief: PureTech Health, a biotechnology firm with a web of startup subsidiaries, announced Tuesday the launch of a new company that will develop a respiratory disease treatment it’s been…

Dive Brief: Insmed has gained approval for its second lung disease medicine, announcing Tuesday Food and Drug Administration clearance of Brinsupri to treat a chronic condition that results in dilated…

Market challenges continue to plague the gene therapy space. Despite their curative potential, many treatments struggle to gain traction once they’re available to patients. Sarepta Therapeutics’ recent roller-coaster ride with Elevidys…

An experimental cancer vaccine fell short of its main objective in a Phase 3 trial in melanoma, causing shares of the shot’s developer, IO Biotech, to fall by double digits…

While direct-to-consumer (DTC) advertising is effective at top-of-funnel awareness and driving action early in the patient journey, it cannot pull through conversions at the pharmacy. Despite massive DTC investments, pharma…

Dive Brief: Eli Lilly’s experimental pill for obesity helped people lose more weight than placebo in a Phase 3 study, but was less effective than Wall Street investors had anticipated,…

For AstraZeneca, a single mutation has launched an entire blockbuster lung cancer franchise. In 2003, the pharma giant began a complicated journey that was almost doomed from the outset. The…

Vinay Prasad will return to lead the Food and Drug Administration office that oversees vaccines and gene therapy in a stunning reversal that comes less than two weeks after he…

Today, a brief rundown of news involving Sarepta Therapeutics and Neumora Therapeutics, as well as updates from Prothena, Jazz Pharmaceuticals and Chai Discovery that you may have missed. Sales of…

Dive Brief: BioNTech on Friday said it will pay as much as $870 million, plus a royalty stream, to CureVac and partner GSK to settle claims that it infringed on…

The Food and Drug Administration has unveiled a new initiative meant to boost U.S. drug manufacturing, responding to a recent Trump administration order to find ways to speed the construction…

Strand Therapeutics has raised a $153 million Series B round fresh off unveiling early, but promising results for a cancer therapy it’s making with messenger RNA technology.  The biotechnology startup…

Novo Nordisk is battling back against the threats to its obesity drug business, saying in an earnings report Wednesday that it expects a significant boost from a major insurer deal…

The Department of Health and Human Services is canceling nearly $500 million in contracts for the development of messenger RNA vaccines in a controversial pivot away from a technology that…

Lawmakers in Washington share U.S. drugmakers’ angst about being surpassed by China’s fast-progressing biotechnology sector, but aren’t raising alarms over the recent surge in licensing deals for medicines discovered there,…

Pfizer and other large pharmaceutical companies are taking seriously President Donald Trump’s demand that drugmakers make more of their medicines available direct to consumers in the U.S. at lower cost,…

A brain-focused biotechnology company saw a double-digit stock drop Monday morning even as it unveiled clinical trial results that some on Wall Street considered top notch. The mid-stage study recruited…

The Gates Foundation on Monday said it is committing to invest $2.5 billion over the next five years to accelerate research and development in neglected areas of women’s health. The…

Moderna said Thursday it plans to lay off 10% of its workforce, or more than 800 employees, as part of an ongoing effort to cut expenses amid slowing vaccine sales.…

Frazier Life Sciences on Thursday said it has closed a new venture capital fund for startup creation and investing in early-stage biotechnology companies, raising $1.3 billion. Frazier is the third…

Biotechnology companies specializing in psychedelics research saw their share prices rise after rumors of a billion-dollar acquisition hinted that big pharma is now more open to betting on this area…

The 17 vaccine advisers fired by Robert F. Kennedy Jr. last month called Wednesday for an alternative to the panel from which they were ousted, arguing that the federal government…

The U.S. plans to lift its pause on country-specific tariffs while implementing a range of new rates for specific trading partners on Aug. 7, per an executive order President Donald…

Today, a brief rundown of news involving Regeneron Pharmaceuticals and Allogene Therapeutics, as well as updates from Bristol Myers Squibb, Biogen, and Argenx that you may have missed. Regeneron said two…

President Donald Trump on Thursday threatened 17 large drugmakers with “every tool in [the federal government’s] arsenal” if they don’t take steps to lower the prices of their products in…

Dive Brief: Sales of an Alnylam Pharmaceuticals rare disease medicine substantially outpaced Wall Street expectations in the drug’s first full quarter since U.S. regulators expanded its use, lifting the biotechnology…

Vinay Prasad’s sudden resignation from the Food and Drug Administration Tuesday once again leaves the biopharmaceutical industry, which has spent much of the year in turmoil, wondering what to expect…

Today, a brief rundown of news involving Madrigal Pharmaceuticals and Viridian Therapeutics, as well as updates from Apellis Pharmaceuticals, PTC Therapeutics and Arrowhead Pharmaceuticals that you may have missed. Seeking…

Vinay Prasad, the controversial head of the Food and Drug Administration office that oversees vaccines and gene therapy, has abruptly left the agency after less than three months on the…

Dive Brief: Merck & Co. is launching a new cost-cutting program, announcing Tuesday a plan to redirect by the end of 2027 $3 billion away from older, slow-growth businesses to…

The Food and Drug Administration has given Sarepta Therapeutics a green light to resume shipping its gene therapy Elevidys to some patients with Duchenne muscular dystrophy, a little over one…

Struggling cancer cell therapy developer Adaptimmune is backing out of commercial drug manufacturing, announcing Monday it will sell its approved medicine Tecelra and two late-stage assets to US WorldMeds in…

An experimental drug from AstraZeneca succeeded in a late-stage trial in an autoimmune condition called generalized myasthenia gravis, positioning the company to grow a business it inherited when acquiring Alexion…

Today, a brief rundown of news involving Rocket Pharmaceuticals and Atara Biotherapeutics, as well as updates from Abivax, Gate Bioscience and Matchpoint Therapeutics that you may have missed. Rocket Pharmaceuticals…

European drug regulators on Friday recommended rejecting Sarepta Therapeutics’ Elevidys in the latest setback for the struggling biotechnology company and its embattled gene therapy for Duchenne muscular dystrophy. The European…

A key committee that helps decide what new medicines enter the European market has changed its mind about a closely watched drug for Alzheimer’s disease, and is now putting its…

AstraZeneca executive Cristian Massacesi will join Bristol Myers Squibb as its chief medical officer, replacing outgoing executive Samit Hirawat, the company said Friday. Massacesi, who served as chief medical officer…

The Food and Drug Administration has delayed its review of a Bayer therapy for hot flashes related to menopause, telling the drugmaker it needs additional to review the company’s application.…

Dive Brief: Galapagos on Wednesday said it’s considering selling its cell therapy business, which previously had been the centerpiece of a restructuring plan.  In January, the Belgian drugmaker said it…

TCG Labs Soleil, a venture firm building narrowly focused biotechnology startups and readying them for partnerships, said Thursday it raised $400 million to continue launching new companies. The firm originally…

Dive Brief: Roche is pausing sales of the Duchenne gene therapy Elevidys in some countries outside the U.S. after partner Sarepta Therapeutics agreed Monday to a Food and Drug Administration…

Health and Human Services Secretary Robert F. Kennedy Jr. on Wednesday endorsed a federal advisory committee’s recommendation to remove a contested preservative from the few influenza vaccines that currently contain…

Today, a brief rundown of news involving Replimune Group and Johnson & Johnson, as well as updates from Omega Funds, iTeos Therapeutics and Roche that you may have missed. The…

Dive Brief: French pharmaceutical giant Sanofi said Tuesday it will pay $1.15 billion to acquire the privately held London-based private biotechnology company Vicebio and its portfolio of experimental vaccines. Through…

WASHINGTON — AstraZeneca, the U.K.’s third biggest company by market value, is making itself a bit more American. On Monday, AstraZeneca CEO Pascal Soriot joined Virginia Governor Glenn Youngkin in…

One month ago, a 51-year-old man treated in a clinical trial with an experimental gene therapy became dangerously sick. The developer of that treatment, Sarepta Therapeutics, informed the Food and…

Johnson & Johnson on Wednesday reported quarterly prescription drug sales that for the first time surpassed $15 billion, highlighting the strength of the pharmaceutical company’s portfolio during a year in…

Bristol Myers Squibb and Pfizer will begin offering their top-selling heart medicine Eliquis through a new online service at a discounted price — the latest example of pharmaceutical companies establishing direct-to-consumer…

Another person treated with a Sarepta Therapeutics gene therapy has died, compounding concerns about the safety of the company’s genetic treatments. Sarepta on Friday confirmed the death of a 51-year-old…

Today, a brief rundown of news involving Bristol Myers Squibb and the Food and Drug Administration, as well as updates from DiaMedica Therapeutics, GSK and PureTech Health that you may…

A panel of medical experts called for the removal of warning labels on hormone therapy for menopausal women during a meeting convened Thursday by the Food and Drug Administration. Led…

The Food and Drug Administration will ask Sarepta Therapeutics to halt all shipments of its marketed gene therapy for Duchenne muscular dystrophy, a source familiar with the matter confirmed to…

Dive Brief: New data from HSBC Innovation Banking add further evidence venture capital funding for private biotechnology companies has slid lower as the year has progressed, erasing what was a…

Novartis is exploring options to meet the Trump administration’s goal of bringing U.S. drug prices down to match what European and other high-income countries pay, but doesn’t expect any policy…

Sarepta Therapeutics is laying off roughly 500 employees in an extensive workforce reduction that follows a series of setbacks and the collapse of the company’s share price this year. In…

An experimental rare disease drug from AstraZeneca failed in two late-stage trials, though the company said Wednesday there were signs of a survival benefit in a prespecified subgroup of patients.…

Dive Brief: An experimental, dual-acting obesity drug from Hengrui Pharma and biotechnology startup Kailera Therapeutics succeeded in a Phase 3 trial in China, positioning the companies to seek approval there…

Dive Brief: LaNova Medicines, a cancer drugmaker that previously licensed medicines to Merck & Co. and AstraZeneca, has agreed to be acquired by Sino BioPharmaceutical in a deal worth up…

A group of private equity firms are pouring funding into PCI Pharma Services, betting the contract drug development and manufacturing organization’s business is poised to grow in the years ahead.…

Dive Brief: An experimental drug being developed by AstraZeneca significantly reduced blood pressure versus placebo in a Phase 3 study of people with either uncontrolled or treatment-resistant hypertension, the pharmaceutical…

The drug industry’s efforts to develop a treatment for a rare kidney condition known in shorthand as ADPKD have come in fits and starts. People with ADPKD, or autosomal dominant…

Dive Brief: AbbVie agreed to pay Ichnos Glenmark $700 million upfront for rights to an early-stage experimental trispecific antibody that has shown promise in multiple myeloma. Under the terms of…

The Food and Drug Administration on Thursday published more than 200 drug rejection letters in a notable policy shift it said will pull back the curtain on feedback the agency…

The Food and Drug Administration has rejected what was set to be the first treatment for heart-related complications of Duchenne muscular dystrophy, indicating that its developer, Capricor Therapeutics, didn’t prove…

Merck & Co.’s $10 billion acquisition of Verona Pharma Wednesday is a dramatic outcome for a company that’s spent 20 years developing a respiratory drug it now sells as Ohtuvayre.…

Today, a brief rundown of news involving Valneva and Jazz Pharmaceuticals, as well as updates from Ultragenyx Pharmaceutical, Nuclidium and Pharvaris that you may have missed. The European Medicines Agency…

Dive Brief: The Food and Drug Administration on Thursday granted full approval for Moderna’s COVID-19 vaccine Spikevax in children aged 6 months through 11 years who are at an increased…

The first marketed treatment for the insatiable hunger associated with Prader-Willi disease is selling more quickly than Wall Street analysts expected, an early, but encouraging sign of demand. According to…

Merck & Co. has agreed to pay $10 billion to buy London-based Verona Pharma, scooping up a potential multibillion-dollar new drug to treat chronic obstructive pulmonary disease in a deal…

Dive Brief: The Food and Drug Administration has approved a modified dosing schedule for Eli Lilly’s Alzheimer’s disease drug Kisunla, permitting a smaller first dose and a more gradual increase…

Dive Brief: Actithera, a radiopharmaceutical drugmaker based in Oslo, Norway and Cambridge, Massachusetts, has raised just under $76 million in Series A venture financing to build out its cancer drug…

Dive Brief: Novartis won regulatory approval Tuesday of the first malaria medicine for newborns and the youngest infants, who until now had no treatment specifically available for them. Regulators in…

Six medical groups and a pregnant physician have sued Health and Human Services Secretary Robert F. Kennedy Jr. and his principal deputies over changes made to federal COVID-19 vaccine recommendations.…

Dive Brief: After a delay due to “resource constraints,” the Food and Drug Administration on Monday approved Kalvista Pharmaceuticals’ pill Ekterly to treat swelling attacks in people with the rare…

Dive Brief: Abbvie has agreed to acquire cell therapy developer Capstan Therapeutics in a deal worth up to $2.1 billion, the companies announced Monday.  The acquisition will hand AbbVie access…

Acadia Pharmaceuticals, the brain-focused drug developer, surprised some on Wall Street last week with a pair of predictions. The first: the company’s two products, which brought in close to $1…

Dive Brief: Organon’s experimental treatment for endometriosis failed to improve pelvic pain for women in a Phase 2 study, leading the company to give up on the drug. The trial…

Today, a brief rundown of news involving Regeneron Pharmaceuticals, IGM Biosciences and Catalio Capital, as well as updates from Roche, Hikma Pharmaceuticals and several others that you may have missed.…

In the notoriously expensive business of drug development, SiteOne Therapeutics made do with little. The biotechnology startup formed in 2010, aiming to create new, non-addictive pain relievers at a time…

Dive Brief: Atai Life Sciences and Beckley Psytech are making plans to push the psychedelic drug mebufotenin into Phase 3 testing after it safely and significantly reduced symptoms of treatment-resistant…

Dive Brief: Sage Therapeutics will lay off 338 employees, the vast majority of its workforce, while in the process of being acquired by Supernus Pharmaceuticals, according to a Massachusetts regulatory…

Dive Brief: Moderna’s seasonal influenza vaccine met its main goal in a large Phase 3 trial, reducing the risk of influenza-like illness in people 50 years and older by 27% compared…

Dive Brief: Incyte has named veteran pharmaceutical executive Bill Meury as its new CEO, replacing longtime head Hervé Hoppenot, who led the cancer and blood disease drugmaker for the past…

Dive Brief: Vor Biopharma is licensing rights to an immune disease drug from Chinese biotechnology company RemeGen, it said Wednesday, a little over one month after announcing plans to review…

Bipartisan policies in Congress meant to lower drug costs by targeting middlemen in the pharmaceutical supply chain are likely to run up against a fundamental issue: the three major pharmacy…

The Supreme Court on Friday upheld a popular provision of the Affordable Care Act that requires private insurers cover a range of preventive healthcare services without cost sharing. The 6-3 ruling…

Today, a brief rundown of news involving Biocryst and Peter Marks, as well as updates from UCB and Altimmune that you may have missed. Biocryst said Friday it is selling…

Dive Brief: The Food and Drug Administration is easing limitations it imposed around the complex cancer drugs known as CAR-T therapies, removing several onerous requirements as well as loosening restrictions on…

Dive Brief: Advisers to the Centers for Disease Control and Prevention recommended Thursday that influenza vaccines used in the coming flu season be free of the preservative thimerosal, addressing unproven…

Acadia Pharmaceuticals has proposed that its pipeline of experimental medicines could, if eventually brought to market, peak at $12 billion in annual sales. The brain drug developer disclosed this estimate…

Robert F. Kennedy Jr.’s newly hand-picked panel of federal vaccine advisers met for the first time Wednesday since the Health and Human Services secretary abruptly fired their predecessors earlier this…

Robert F. Kennedy Jr.’s newly hand-picked panel of federal vaccine advisers met for the first time Wednesday since the Health and Human Services secretary abruptly fired their predecessors earlier this…

Dive Brief: Kymera Therapeutics and Gilead Sciences will develop oral molecular glue degraders under a deal announced Wednesday, which could hand the former as much as $85 million in upfront…

Today, a brief rundown of news involving Sarepta Therapeutics, Capricor Therapeutics and Nektar Therapeutics, as well as updates from AstraZeneca, Revolution Medicines and Carisma Therapeutics that you may have missed.…

Senator Bill Cassidy, a powerful Republican senator from Louisiana, has called for an important federal vaccine meeting this week to be delayed, after Health and Human Services Secretary Robert F.…

On the heels of the BIO International Convention and as I reflect on the passion for innovation that drives this industry, one truth I keep coming back to is this:…

Dive Brief: Shares of San Diego biotechnology company Cidara Therapeutics doubled Monday after the company revealed positive mid-stage study results for an experimental preventive therapy it’s developing for seasonal influenza.…

Dive Brief: Actio Biosciences, a San Diego-based biotechnology startup, announced Wednesday it raised a $66 million Series B financing to support drug research it’s initially aiming at rare genetic diseases,…

Dive Brief: Two senior officials at the Food and Drug Administration office that regulates gene therapies have reportedly been placed on administrative leave, resurfacing questions about the way the complex…

Biotechnology industry watchers were hopeful at the start of 2025. Venture funding appeared to be rebounding after a lengthy slump, and a smattering of new stock offerings and company acquisitions…

Today, a brief rundown of news involving Prothena and Zealand Pharma, as well as updates from Biogen and Sanofi that you may have missed. Prothena is laying off 63% of…

Food and Drug Administration Commissioner Martin Makary has proposed a dramatic expansion of the agency’s powers to speed up drug reviews, announcing on Tuesday a plan to evaluate new medicines…

Psychiatric medicine remains one of the more challenging and risky areas of drug research. Many prospects show initial promise only to fail later on. Still, recent breakthroughs are spurring more…

The Food and Drug Administration has approved a new way to prevent HIV, clearing a Gilead Sciences drug that requires only two injections a year to protect against infections.  The…

Dive Brief: A medicine developed to treat a genetic muscle-wasting disease can improve results for patients taking GLP-1 weight-loss medicines, according to a new Phase 2 study. Scholar Rock has…

Today, a brief rundown of news involving CSL and Intellia Therapeutics, as well as updates from Eli Lilly and 23andme that you may have missed. The Food and Drug Administration on…

Dive Brief: Eli Lilly agreed to buy Verve Therapeutics for $1 billion, betting on the promise of one-and-done gene therapies to treat cardiovascular disease.  The deal announced Tuesday offers Verve…

When the deadline to appeal the court decision that blocked the Food and Drug Administration’s final rule regulating laboratory developed tests as medical devices slipped by in May without a…

Dive Brief: Sage Therapeutics, a brain drug developer that’s dealt with a series of clinical setbacks, has agreed to be acquired by Supernus Pharmaceuticals in a deal worth $561 million. …

Dive Brief: The Food and Drug Administration has approved a new oral medication for an uncommon kind of tumor, clearing Nuvation Bio’s Ibtrozi on Wednesday for certain people whose metastatic…

Today, a brief rundown of news involving Insmed and Recursion Pharmaceuticals, as well as updates from Odyssey Therapeutics, Gilead Sciences and Novo Nordisk that you may have missed. Insmed said…

The budget bill currently under consideration in Congress is big — and it’s complicated. The 1,000-plus page document is full of tax and spending cuts, including some significant changes that…

Listen to the article 4 min This audio is auto-generated. Please let us know if you have feedback. Today, a brief rundown of news involving AstraZeneca and Third Harmonic Bio,…

The Food and Drug Administration has approved wider use of Moderna’s respiratory syncytial virus vaccine in a boost for a company that’s been negatively impacted by the recent leadership changes…

Dive Brief: Novo Nordisk is planning Phase 3 clinical trials for a obesity drug combination called amycretin, adding another emerging weight-loss medicine to the list of prospects it has in…

Health and Human Services Secretary Robert F. Kennedy Jr. on Wednesday continued his efforts to alter the government structure supporting immunizations, naming vaccine skeptics and doctors with different focus areas…

Dive Brief: COVID vaccine maker BioNTech is buying rival CureVac, announcing Thursday an all-stock deal weeks before the two companies were due to face off in a German court over potentially…

Dive Brief: Bristol Myers agreed to pay $350 million up front to Philochem for worldwide rights to an experimental radiopharmaceutical to diagnose and treat prostate cancer. The agent, OncoACP3, has…

SpliceBio, a Spanish biotechnology company working on next-generation gene therapies, said Wednesday it raised $135 million in a Series B round to advance its lead program in Stargardt disease into…

Dive Brief: Health and Human Services secretary Robert F. Kennedy Jr., has abruptly fired all members of the committee guiding the Centers for Disease Control and Prevention’s vaccine recommendations, creating…

Fresh off a multibillion-dollar deal with Eli Lilly, cancer drug startup Scorpion Therapeutics is trying for an encore, debuting a successor company on Tuesday that’s carrying forward much of its…

The Food and Drug Administration has cleared a new treatment designed to protect infants from respiratory syncytial virus. Called Enflonsia and developed by Merck & Co., the drug is an…

Dive Brief: An experimental weight loss drug developed by Metsera helped people with obesity lose up to 8% of their body weight over five weeks in an early-stage clinical trial…

Today, a brief rundown of news involving Regeneron and Bluebird bio, as well as updates from Atai Life Sciences, Alto Neuroscience and UniQure that you may have missed. Regeneron Pharmaceuticals…

The amount of funding going into biotechnology companies has fallen off over the last couple months, a trend the investment bank Jefferies pins on Trump administration policies aimed at gutting…

New drugs, however heralded, take time to embed into clinical care. Enhertu, the powerful antibody-drug conjugate from Daiichi Sankyo and AstraZeneca, was first approved in the U.S. in 2019, before…

The Food and Drug Administration aims to roll out its new AI tool, called Elsa, “ahead of schedule and under budget,” according to Commissioner Marty Makary, who offered up the…

Anyone looking for evidence of genetic medicine’s enormous promise need only read of KJ Muldoon. The 10-month-old infant headed home from a Philadelphia hospital this week, dressed in a celebratory…

Today, a brief rundown of news involving Otsuka Pharmaceutical and Arvinas, as well as updates from Regenxbio, Vigil Neuroscience and Sagimet Biosciences that you may have missed. Vera Therapeutics lost…

CHICAGO — Hiroyuki Okuzawa holds an enviable position. The veteran Daiichi Sankyo executive took over as the Japanese drugmaker’s new CEO two months ago and inherited a company whose cancer…

Dive Brief: After changing its name and focus, Cullinan Therapeutics is beefing up its autoimmune disease pipeline by licensing an experimental drug from China. The company will pay Genrix Bio…

Dive Brief: The Food and Drug Administration has awarded Sarepta Therapeutics a new kind of fast pass that could help speed the reviews of certain gene therapy applications it brings…

Dive Brief: Looking to defend its giant cardiometabolic health franchise, Eli Lilly is licensing a technology from Swedish biotechnology firm Camurus that promises to produce longer-acting medications. Camurus’ FluidCrystal technology…

CHICAGO — A Johnson & Johnson drug currently used for advanced prostate cancer can help keep the disease from progressing in men who are at earlier stages and have certain genetic…

An experimental, non-hormonal drug from Bayer can reduce the hot flashes and other menopausal side effects many women taking a common breast cancer therapy experience, according to results from a…

Dive Brief: An experimental protein-degrading drug from Kymera Therapeutics appeared safe and able to affect its intended target in an early-stage clinical trial, leading shares in the biotechnology company to…

Listen to the article 4 min This audio is auto-generated. Please let us know if you have feedback. Dive Brief: An experimental medicine from Vera Therapeutics succeeded in a late-stage…

CHICAGO — Funding cancer research isn't usually a political flashpoint. But as the Trump administration signals its desire to drastically cut the budget of the National Cancer Institute, the American…

Too often, cancer has a way of evading treatment. Tumors that were held in check begin to spread anew, forcing doctors to try different drugs in a desperate race to…

The Food and Drug Administration has granted an approval to Moderna’s next-generation COVID-19 vaccine, but with limits that will restrict use to older adults and people with preexisting health conditions.…

AstraZeneca and Daiichi Sankyo’s targeted cancer medicine Enhertu helped participants in a late-stage clinical trial with a type of advanced gastric cancer live longer than those who received a commonly…

Today, a brief rundown of news involving Astellas Pharma and Keros Therapeutics, as well as updates from Stealth Biotherapeutics, PepGen and Taysha Gene Therapies that you may have missed. Keros…

Dive Brief: A dual-acting drug developed by Summit Therapeutics and Akeso delayed tumor progression in a Phase 3 lung cancer trial but didn’t extend survival, complicating its potential path to…

The U.S. The Department of Health and Human Services has canceled a contract with Moderna to develop messenger RNA vaccines against influenza strains seen as potential pandemic risks, leaving the…

Dive Brief: Intellia Therapeutics shares dropped 25% early Thursday after the gene-editing company disclosed that one patient in an ongoing Phase 3 trial had signs of liver stress. Lab tests…

Dive Brief: Cancer drugmaker iTeos Therapeutics said Wednesday it plans to wind down operations and seek to sell the company’s assets and intellectual property rights. ITeos has for years struggled…

Dive Brief: GSK plans to seek approval of a new antibiotic for complicated urinary tract infections after the drug succeeded in a Phase 3 trial. An independent monitoring board recommended…

Dive Brief: The Food and Drug Administration on Thursday recommended COVID-19 vaccine manufacturers tailor their shots for the upcoming fall and winter season to target the “JN.1” strain, ideally a subvariant…

A biotechnology startup developing drugs designed to eliminate troublesome proteins found outside of cells has raised $130 million to start its first clinical trial. The startup, GlycoEra, will use the…

Dive Brief: After discussions with the Food and Drug Administration, Moderna on Wednesday said it has voluntarily withdrawn its application for a combination COVID-19 and influenza shot in adults aged…