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  • STAT+: RA Capital backs upstart rival to Ultragenyx and Ionis in rare brain disease
    Oak Hill Bio, a new company backed by RA Capital and other investors, will take on Ultragenyx and Ionis in developing an Angelman syndrome medicine.
    STAT · 1d agoDealNeutral↗ source
  • Argenx to pick up autoimmune biotech Forte Biosciences for $2.2B
    Argenx will spend $2.2 billion to buy Forte Biosciences and its anti-CD122 monoclonal antibody that’s under investigation for autoimmune diseases. The Belgian-Dutch pharma said Monday it will pay $…
    Endpoints · 1d agoDealNeutral↗ source
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  • STAT+: Argenx to buy Forte Biosciences for $2.2B
    Argenx plans to buy Forte Biosciences for $2.2 billion, expanding its pipeline of drugs that could treat multiple autoimmune diseases.
    STAT · 2d agoDealNeutral↗ source
  • STAT+: HIV resurgence is feared as global funding to combat the disease falls 18%
    The world risks a resurgence of the HIV epidemic after international financing to combat the disease suffered a “profound shock” last year, according to a new report from UNAIDS.
    STAT · 1d agoRegulatoryNeutral↗ source
  • Virginia federal judge says FDA should reconsider mifepristone restrictions
    At a time when the federal government is evaluating restrictions on medication abortion, a federal judge determined that the last administration imposed too many. A Virginia federal judge ordered t…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • STAT+: Pharma’s drug spending deflection
    Job lock, surging prescription drug costs, No Surprises Act update, and more from STAT's Health Care Inc.
    STAT · 1d agoRegulatoryNeutral↗ source
  • Capricor's DMD therapy lacks efficacy, FDA says ahead of adcomm
    The FDA is again questioning the efficacy of Capricor's cell therapy for Duchenne muscular dystrophy, this time ahead of an advisory committee meeting on Wednesday. The agency's review team said it…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • Six wellness peptides win backing from FDA advisory committee
    After two days of meetings, an FDA advisory committee last week voted to lift restrictions on six popular health and wellness peptides, setting aside FDA staff concerns about a lack of safety and e…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • MapLight dives despite positive data for schizophrenia drug
    Shares fell more than 66% Monday morning, which analysts suspect is due to investors seeing the data as not competitive with Bristol Myers' Cobenfy.
    BioPharma Dive · 1d agoRegulatoryNeutral↗ source
  • MapLight’s schizophrenia pill remains in Cobenfy’s shadow after mixed Phase 2 readout
    While MapLight Therapeutics’ oral schizophrenia candidate reached the main endpoint of a Phase 2 trial, analysts say Bristol Myers Squibb's Cobenfy is likely to hold its market share.
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • Gossamer regains rights to lung disease asset from Chiesi after Phase 3 fail
    Despite a Phase 3 miss, Gossamer Bio is full steam ahead for its lung disease asset, pointing to previous “review issues” at the FDA as one of the reasons to continue development.
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • Sarepta names former AbbVie R&D exec Michael Severino as next CEO
    After leaving Tessera Therapeutics earlier this month, Michael Severino will take over Sarepta Therapeutics as the biotech awaits two key regulatory decisions in Duchenne muscular dystrophy.
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • Sarepta, in search of a turnaround, taps ex-AbbVie exec Severino as CEO
    Most recently the leader of buzzy startup Tessera Therapeutics, Severino will look to improve the fortunes of a company facing emerging competition and declining sales for its prized gene therapy E…
    BioPharma Dive · 1d agoRegulatoryNeutral↗ source
  • STAT+: Sarepta names Michael Severino, former Tessera CEO, as new chief executive
    The beleaguered Sarepta Therapeutics named Michael Severino, who previously led Tessera Therapeutics, as its new CEO.
    STAT · 1d agoRegulatoryNeutral↗ source
  • STAT+: Pharmalittle: We’re reading about a U.S. peptide panel’s votes, Amgen scuffling with the FDA, and more
    An FDA panel recommended that compounding pharmacies be allowed to make two more peptides, a step toward RFK Jr.'s goal to make them more available
    STAT · 1d agoRegulatoryNeutral↗ source
  • STAT+: Ahead of hearing, FDA questions the efficacy of Capricor’s Duchenne drug
    Ahead of a hearing, the FDA raised questions about the benefits of a Duchenne treatment from Capricor Therapeutics, another twist for the rare disease drug.
    STAT · 1d agoRegulatoryNeutral↗ source
  • A trend that isn’t fading, ultra-processed baby foods
    An FDA advisory panel serves some peptide wins, a measles record, and more health news from Morning Rounds
    STAT · 1d agoRegulatoryNeutral↗ source
  • [Podcast] From Protocol to Patient: Inside Clinical Supply with Almac Clinical Services
    This podcast explores how clinical trial supplies move from early planning to global delivery, ensuring investigational medicines reach patients safely and on time.
    BioPharma Dive · 1d agoRegulatoryNeutral↗ source
  • [Podcast] (Season 2) The Progress Profile: Alzheimer’s Research in Focus
    This podcast explores how leading Alzheimer’s experts are working to bridge the gap between clinical trial design and frontline care.
    BioPharma Dive · 1d agoRegulatoryNeutral↗ source
  • From confidence to capital: Positioning biotech for the next growth cycle
    How can biotechs be investor ready? Key takeaways from BIO International and DIA China 2026.
    BioPharma Dive · 2d agoRegulatoryNeutral↗ source
  • Opinion: How midwives like me can help fight medical misinformation
    “I have come to believe that changing a mind is rarely the point. Planting a seed is,” writes nurse-midwife Mara Evans.
    STAT · 2d agoRegulatoryNeutral↗ source
  • STAT+: As some medical schools embrace RFK Jr.’s nutrition push, they deftly sidestep MAHA priorities
    Even as some medical schools heed health secretary Robert F. Kennedy Jr.’s call for more nutrition education, several told STAT that they plan to steer clear of topics that aren’t…
    STAT · 2d agoRegulatoryNeutral↗ source
  • Opinion: E-bikes, e-scooters are a burgeoning pediatric public health emergency
    “Emergency departments across America report dramatic increases in serious injuries from e-bikes and e-scooters,” write CHOP’s J. Todd R. Lawrence and Madison A. Kesler.
    STAT · 2d agoRegulatoryNeutral↗ source
  • Denmark’s foundation‑fueled biotech boom redraws the Nordic map
    Investment and a maturing talent base have propelled Denmark ahead of its Nordic peers, drawing Swedish companies and exposing regional gaps in capital and scale.
    BioSpace · 2d agoRegulatoryNeutral↗ source
  • FDA schedules advisory committee meetings for rejected Replimune melanoma drug and Capricor DMD cell therapy
    The FDA announced that it will hold two advisory committee meetings this week to revisit investigational therapies that were previously turned down. One meeting will consider Capricor Therapeutics'…
    BioSpace · 2d agoRegulatoryNeutral↗ source