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  • 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 · 4h ago↗ source
  • FDA adcomm votes in favor of lifting restrictions on popular wellness peptide BPC-157
    An FDA advisory committee voted Thursday to recommend expanding access to a popular peptide used by health and wellness enthusiasts for repairing muscles and healing injuries. The recommendation se…
    Endpoints · 6h ago↗ source
  • FDA to end pilot aimed at preventing production issues
    The FDA said it will end a pilot that was intended to help drugmakers proactively address production issues. Few companies took advantage of the program during its three-year run. In April 2027,…
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Pulmonology5
Infectious Disease4
Ophthalmology3
Dermatology2
Endpoints · 6h 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 · 7h 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 · 7h 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 · 8h 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 · 8h 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 · 8h ago↗ source
  • Sartorius reduces revenue by €26M to refund Trump tariffs to customers
    Sartorius appears to be the first life science company to detail how tariff refunds are affecting its revenue, following the US Supreme Court decision to block some of President Donald Trump’s levi…
    Endpoints · 8h ago↗ source
  • Lilly, with new data, to seek FDA approval of obesity drug retatrutide
    <figure><div><img src="https://imgproxy.divecdn.com/x5fF_ZCHHBjPFAGFuuKXSVkAgBGYTo2hZBIz9OcQdEo/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMDkyNDczMjEzLmpwZ…
    BioPharma Dive · 9h 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 · 9h 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 · 9h ago↗ source
  • Merck CEO cautions Congress on imposing limits on Chinese dealmaking
    Merck CEO Rob Davis said he has warned Congress and the Trump administration that if they cut off or hamper US-China dealmaking, the US could lose its status as the world's biotech leader. China-…
    Endpoints · 9h ago↗ source
  • Scancell plans Neuphoria merger; AstraZeneca wins EU nod for cancer drug
    Scancell to merge into Neuphoria: Scancell plans to take over Neuphoria Therapeutics' Nasdaq listing {$NEUP} and change the ticker to SCLT. The company eyes up to $89 million in equity and ...
    Endpoints · 10h 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 · 10h ago↗ source
  • CLINUVEL will cut up to 20% of staff, relocate HQ to New York
    Follow along as BioSpace tracks job cuts and restructuring initiatives.
    BioSpace · 10h 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 · 10h 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 · 10h ago↗ source
  • Biogen counts on drugs from Apellis deal to patch Leqembi's slow sales
    It’s no secret that sales of Leqembi have been disappointing. First approved in 2023, the Alzheimer’s drug from Eisai and Biogen launched shortly after Chris Viehbacher took the reins as Biogen C…
    Endpoints · 10h ago↗ source
  • What’s behind the proposed pullback on remote patient monitoring
    Companies that help doctors keep tabs on their patients at home are freaking out after Medicare's proposal last week to gut remote patient monitoring, or RPM. The plan is a total about-face from…
    Endpoints · 10h 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 · 10h 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 · 11h 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 · 11h ago↗ source
  • Repligen’s $1.5B buy for BioLife; BeOne’s $300M US expansion
    Plus, news about Lonza, Bachem and Samsung Biologics. 🤝 Repligen to acquire BioLife Solutions: Repligen will pay around $1.5 billion for cell processing service supplier BioLife, 36% of which w…
    Endpoints · 11h 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 · 11h ago↗ source