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  • Whoop appoints new chief medical officer, discusses health tech plans and CMS initiative
    STAT Health Tech’s latest newsletter features a brief interview with Whoop’s newly appointed chief medical officer. The CMO fielded three questions about the company’s direction, wearable data use…
    STAT · 4d agoNeutral↗ source
  • Argenx to buy Forte Biosciences for up to $2.2 billion, adding experimental CD122 drug FB102
    Argenx announced it will acquire Forte Biosciences in a transaction valued at up to $2.2 billion. The purchase price is set at $77 per Forte share, roughly a 41% premium to the previous closing pr…
    BioPharma Dive · 5d agoDealPositive↗ source
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  • Global HIV funding drops 18%, raising fears of epidemic resurgence
    A new UNAIDS report warns that the world could see a rebound of HIV infections after donor financing fell sharply last year. Government contributions dropped by more than $1.5 billion to $7.3 bill…
    STAT · 5d agoNegative↗ source
  • PhRMA pushes back as prescription drug spending continues to rise, according to STAT+ newsletter
    STAT+ Health Care Inc. newsletter author Bob Herman reports on the growing concern that prescription drug spending is rising despite industry attempts to downplay it. The piece appears in the July…
    STAT · 5d agoNegative↗ source
  • MapLight shares plunge 66% after mid-stage schizophrenia trial shows modest benefit but raises competitive concerns
    MapLight Therapeutics announced results from its mid‑stage trial of an experimental schizophrenia drug. The study enrolled adults experiencing an acute exacerbation of psychotic symptoms. The twic…
    BioPharma Dive · 5d agoPositive readoutNegative↗ source
  • FDA staff raise concerns over Capricor’s Duchenne cell therapy as shares plunge; Legend CEO resigns, AstraZeneca reports pipeline woes
    Capricor Therapeutics saw its shares tumble by nearly two‑thirds after FDA reviewers highlighted serious concerns about the data supporting its experimental Duchenne muscular dystrophy cell therapy…
    BioPharma Dive · 5d agoRegulatoryNegative↗ source
  • Sarepta appoints former AbbVie executive Michael Severino as new CEO to drive turnaround
    Sarepta Therapeutics announced that Michael Severino will become its chief executive officer on July 28, succeeding Doug Ingram who plans to retire. Severino brings more than two decades of experi…
    BioPharma Dive · 5d agoNeutral↗ source
  • FDA doubts efficacy of Capricor’s Duchenne stem-cell therapy after Phase 3 miss
    The U.S. Food and Drug Administration said Monday that Capricor Therapeutics’ stem‑cell treatment for Duchenne muscular dystrophy failed to meet the primary goals of its Phase 3 trial, contradictin…
    STAT · 5d agoRegulatoryNegative↗ source
  • WHO publishes first interim list of medical device authorities; AstraZeneca explores AI to reduce late-stage risk
    The World Health Organization has issued its first interim list of medical device authorities, marking a step toward greater transparency in device regulation. The list is intended to guide manufac…
    raps · 6d agoRegulatoryNeutral↗ source
  • EMA commits to safeguarding stakeholder data; FDA advisory panel expands compounding peptide list
    The European Medicines Agency announced that it will assume ultimate responsibility for protecting information submitted by stakeholders through online meeting registrations and surveys, in line wi…
    raps · 6d agoRegulatoryNeutral↗ source
  • FDA issues three new guidances to expand eligibility criteria for cancer trials
    The FDA's Oncology Center of Excellence has released three final guidance documents aimed at widening the pool of patients who can enroll in oncology clinical trials. The guidances focus on three…
    raps · 6d agoRegulatoryNeutral↗ source
  • Sarepta Therapeutics appoints Michael Severino, former Tessera CEO, as new chief executive
    Sarepta Therapeutics announced that Michael Severino will become its chief executive, effective Tuesday. Severino previously led Tessera Therapeutics. He replaces Doug Ingram, who said he will ret…
    STAT · 5d agoNeutral↗ source
  • 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 · 5d agoDealNeutral↗ source
  • 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 · 5d agoDealNeutral↗ source
  • Study shows drug development and reimbursement timelines align across four major markets
    Researchers published a cross‑sectional analysis in JAMA Health Forum examining how long it takes for a drug to move from the start of clinical trials to receiving reimbursement approval. The anal…
    raps · 6d agoNeutral↗ source
  • FDA panel backs compounding pharmacies to make two peptides, rejects third
    The U.S. Food and Drug Administration’s advisory committee met on Friday and issued recommendations on the manufacturing of certain peptide drugs by compounding pharmacies. Committee members voted…
    STAT · 5d 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 · 5d 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 · 5d 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 · 5d 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 · 5d 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 · 5d 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 · 5d 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 · 5d agoRegulatoryNeutral↗ source
  • Australia's TGA adopts 23 international scientific guidelines from EMA, ICH and FDA
    The Therapeutic Goods Administration (TGA) in Australia announced it has formally adopted 23 scientific guidelines. The guidelines come from the European Medicines Agency, the International Counci…
    raps · 6d agoRegulatoryNeutral↗ source
  • FDA panel backs compounding of epitalon, rejects emideltide in narrow vote
    The FDA advisory committee voted to allow compounding pharmacies to produce the peptide epitalon, while narrowly voting against allowing the production of emideltide. The decision follows the pane…
    STAT · 8d agoRegulatoryNeutral↗ source