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1,466 stories matching this filter · ← front page

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  • Scribe records upsized $129M IPO to bankroll lipid-lowering genetic meds
    In vivo gene editing outfit Scribe Therapeutics has priced its IPO at $128.7 million, surpassing the $96 million goal set out earlier this week.
    Fierce Biotech · 7d ago↗ source
  • FDA panel endorses broader use of certain peptides
    In a victory for Robert F. Kennedy Jr.’s “MAHA” agenda, panelists narrowly recommended broader use of six of the seven peptides up for consideration despite a lack of substantive evidence supportin…
    BioPharma Dive · 7d ago↗ source
  • This Week at FDA: Diamantas touts onshoring efforts, grants for DHTs, and more
    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This we…
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fda recalls22
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fda medwatch17
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Endocrinology & Metabolism289
Ophthalmology255
Infectious Disease252
Nephrology234
raps · 7d ago
↗ source
  • FDA advisory committee backs two more peptides, rejects one for compounding list
    By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration (FDA) voted in favor of adding six of the seven peptides it was tasked…
    raps · 7d ago↗ source
  • STAT+: In win for RFK Jr., FDA advisory panel narrowly votes to allow compounding of unapproved peptides
    The panel recommended allowing compounding pharmacies to produce popular but unproven BPC-157 and KPV peptides.
    STAT · 7d ago↗ source
  • Update: FDA does not freeze CRL trove as ‘radical transparency’ push hits speedbump
    An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”
    BioSpace · 7d ago↗ source
  • U.S. health officials are investigating a new outbreak of a diarrhea-causing parasite
    Federal health officials are investigating a new outbreak involving the diarrhea-causing parasite cyclospora.
    STAT · 7d ago↗ source
  • Chutes & Ladders—Biogen R&D vet gets in Formation
    AI-focused Formation Bio has found a new chief scientist with extensive experience in biotech, Big Pharma and academia. Michael Ehlers, M.D., Ph.D., is joining the 2025 Fierce 15 honoree as chief s…
    Fierce Biotech · 7d ago↗ source
  • STAT+: European regulators take steps to bolster clinical trial transparency
    The European Medicines Agency is taking what advocacy groups are calling unexpectedly “rapid action” to ensure that clinical trial results are made public as required by law.
    STAT · 7d ago↗ source
  • STAT+: Popular insulin product enters shortage as other pens leave market
    The Lantus Solostar insulin pen isn't in official FDA shortage, but patients are having a tough time finding it.
    STAT · 7d ago↗ source
  • Senate health panel delays vote on CDC nominee
    Too few senators were in attendance to proceed with a vote on the CDC director nominee.
    STAT · 7d ago↗ source
  • Lilly, with new data, to seek FDA approval of obesity drug retatrutide
    The new findings position Lilly to file an application for the highly anticipated medicine, but also leave some questions about the additive benefits a “triple-G” drug has on heart health.
    BioPharma Dive · 7d ago↗ source
  • STAT+: What’s in the last-minute flurry of health care bills?
    Congress is scrambling to advance a slew of health care bills before an August recess. Price transparency and prior authorization top the list.
    STAT · 8d ago↗ source
  • FDA panel confronting peptide controversy
    Today's biotech news features the FDA weighing the fate of peptides; approvals for RevMed, GSK; and data on Lilly's "triple-G."
    STAT · 8d ago↗ source
  • A father’s mission to save his daughter, and allegations on telehealth GLP-1 prescribing
    Has a wanted fugitive been posing as a biotech executive? And what does it take to develop a therapy for an ultra-rare disease? Find out on this week's episode of…
    STAT · 8d ago↗ source
  • From Abu Dhabi to Brazil, every region is vying for the ‘new emerging economy’ of biotech
    Whether it's looming tariff threats or the rise of China, you need a truly global view to navigate today's biopharma industry.
    Fierce Biotech · 8d ago↗ source
  • BeOne commits $300M to US manufacturing expansion, creating 120 new jobs
    The addition of small molecule capacity at BeOne Medicines’ Hopewell site will support the company’s hematology efforts and bring total investment in the campus to more than $1 billion.
    BioSpace · 8d ago↗ source
  • STAT+: Vote on key federal health nominee delayed amid questions over vaccine views
    Sean Kaufman, nominated to run ASPR, has a track record of questioning the safety of vaccines.
    STAT · 8d ago↗ source
  • STAT+: Trump administration quietly picks Timothy Westlake to lead mental health agency
    Timothy Westlake, an emergency doctor nominated to head SAMHSA, has been active in addiction policy in Wisconsin.
    STAT · 8d ago↗ source
  • STAT+: Pharmalittle: We’re reading about Lilly obesity drug data, a push for FDA to ban DTC ads, and more
    A study of Lilly's retatrutide weight loss drug in people with heart disease did not answer a crucial question — whether it reduces cardiovascular risk
    STAT · 8d ago↗ source
  • STAT+: HHS to convene experts on standards for clinical AI
    In this edition of STAT Health Tech: HHS is inviting experts to shape policy on clinical AI, Whoop's new CMO, news about brain implants, and more.
    STAT · 8d ago↗ source
  • STAT+: FDA is urged by advocacy group to ban DTC prescription drug ads
    A leading advocacy group petitioned the FDA to ban direct-to-consumer advertising of prescription medicines.
    STAT · 8d ago↗ source
  • Lilly preps FDA run for ‘triple-G’ weight loss drug with Phase 3 data
    With weight loss topping 20% at 80 weeks in the Phase 3 TRIUMPH-2 and TRIUMPH-3 trials, Eli Lilly plans to file for retatrutide’s approval in the first quarter of 2027. Previously a filing was expe…
    BioSpace · 8d ago↗ source
  • Roche's late stage pipeline 'so full,' CEO Schinecker not feeling pressure to add on
    Roche has 19 investigational medicines that could launch by 2030—and even if not all of them make it to market, the company is “well set-up for growth into the next decade,” CEO Thomas Schinecker s…
    BioSpace · 8d ago↗ source
  • GSK’s $10.6B Nuvalent bet pays off early as FDA approves lung cancer drug
    Jideytro is GSK’s first approved product for lung cancer. With its takeover of Nuvalent Bio last month and a deal with Hansoh Pharmaceutical in 2023, the pharma now has several other lung cancer as…
    BioSpace · 8d ago↗ source