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1,636 stories matching this filter · ← front page

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  • Epicrispr raises $90 million to push epigenetic editing drug EPI-321 for rare muscle disorder FSHD
    Epicrispr Biotechnologies announced a $90 million Series C financing to accelerate development of its epigenetic editing therapy EPI-321 for facioscapulohumeral muscular dystrophy (FSHD), a rare ge…
    BioPharma Dive · 2h agoDealPositive↗ source
  • Medicare’s new $50 GLP‑1 weight‑loss drug program may create barriers for patients, warns experts
    Medicare has launched a program that caps out‑of‑pocket costs for GLP‑1 weight‑loss medicines such as Wegovy, Zepbound and Foundayo at $50 a month for eligible beneficiaries. The initiative is inte…
    STAT · 5h agoRegulatoryNegative↗ source
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  • Nurses voice concerns on AI while regulators outline RAPID pathway for breakthrough devices
    The latest STAT Health Tech newsletter, dated August 11, 2026, highlights two contrasting developments in health technology. Nurses interviewed for the piece express skepticism about the impact of…
    STAT · 44m agoRegulatoryNeutral↗ source
  • Nonprofit North Star Review Board offers independent model to fix IRB oversight issues
    Founders Stephen Rosenfeld and Patricia Seymour created the not‑for‑profit North Star Review Board after becoming disillusioned with the current system of institutional review boards (IRBs) that ov…
    STAT · 5h agoRegulatoryNeutral↗ source
  • Nurses push for involvement as AI threatens jobs and patient care
    Nurses, the largest segment of the health‑care workforce, are increasingly vocal about the risks that clinical artificial intelligence poses to their employment and to patient safety. At Montefior…
    STAT · 5h agoNegative↗ source
  • Abortion care shifts to remote and private channels as patients seek help outside clinics
    Patients are increasingly turning to non‑clinical avenues for abortion information, a trend that began before the Dobbs decision. A family physician recounts a recent encrypted message from a teena…
    STAT · 5h agoNeutral↗ source
  • STAT+: Skylark Bio kicks off new gene therapy trial for deafness
    Biotech startups in the U.S., France, and China are racing to bring new gene therapies for deafness by targeting different genetic mutations.
    STAT · 2h ago↗ source
  • Vaderis hauls in $152M to test an AKT-targeting drug
    The startup is one of at least a few young companies zeroing in on the rare bleeding disorder, hereditary hemorrhagic telangiectasia, with a more precise AKT blocker.
    BioPharma Dive · 3h ago↗ source
  • STAT+: Why is MoonLake Immunotherapeutics scared of releasing data on its drug candidate?
    Biotech companies don’t hide or obfuscate strong data.
    STAT · 5h ago↗ source
  • Abbott teams with Google Health on AI-powered health insights app
    Two giants of their respective fields, Abbott and Google, are joining forces for a first-of-its-kind team-up that aims to build out a digital picture of people’s health.
    Fierce Biotech · 10h ago↗ source
  • FDA issues early alert after BD needle set defects linked to four deaths
    The FDA’s Center for Devices and Radiological Health released an early alert warning clinicians to stop using Becton Dickinson’s intraosseous vascular access needle sets after reports of serious in…
    Fierce Biotech · 1d agoRegulatoryNegative↗ source
  • Scribe Therapeutics launches first gene‑editing IPO in over two years, targeting high‑cholesterol gene
    Scribe Therapeutics, a gene‑editing biotech based in California, announced its initial public offering, the first for a CRISPR‑focused company in more than two years. The company, founded by resea…
    BioPharma Dive · 23h agoDealPositive↗ source
  • Sionna’s cystic fibrosis flop sends stock down 90%, but a ‘significant positive’ for Vertex
    Sionna Therapeutics has axed a cystic fibrosis add-on program after flunking a phase 2 trial, eliminating a would-be challenger to Vertex Pharmaceuticals’ empire. The biotech plans to “take actions…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • AbCellera's Phase 2 hot flash trial beats aggressive upside target, challenging Astellas and Bayer
    AbCellera announced that its Phase 2 study of ABCL635, an antibody that blocks the NK3R receptor, met its primary endpoint in postmenopausal women with hot flashes. The trial enrolled 92 participan…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Jazz Pharmaceuticals to acquire Actio Biosciences in deal worth over $1.3 billion
    Jazz Pharmaceuticals announced an agreement to purchase Actio Biosciences, a San Diego biotech focused on genetic epilepsies. The transaction could total just over $1.3 billion, with $820 million…
    BioPharma Dive · 22h agoDealPositive↗ source
  • FDA advisory panel set to review Grail’s multi-cancer Galleri screening test
    An FDA advisory committee is scheduled to evaluate Grail’s Galleri blood test, which is designed to detect a range of cancers at an early stage. The panel will examine the test’s clinical data, pe…
    STAT · 23h agoRegulatoryNeutral↗ source
  • Sionna's CF add-on pill fails to improve outcomes in Phase 2 trial with Trikafta
    Sionna Therapeutics reported that its experimental cystic fibrosis pill, SION-719, did not provide any additional benefit when combined with Vertex Pharmaceuticals' Trikafta in a Phase 2 study. Th…
    STAT · 1d agoNegative readoutNegative↗ source
  • Jazz Pharma to acquire Actio Biosciences for $820M, adding KCNT1+ epilepsy drug to its pipeline
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences for an upfront payment of $820 million, expanding its portfolio of epilepsy medicines. The deal brings Actio’s lead candidate, ABS…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Silence Therapeutics’ Phase 2 Trial Shows Strong Efficacy of divesiran in Polycythemia Vera
    Silence Therapeutics reported that its siRNA candidate divesiran met the primary endpoint in a phase 2 study of patients with polycythemia vera. The trial enrolled 48 participants and 88% of those…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • BMS to build $2.3 B Houston plant as MHRA clears Lilly's weight-loss drug; IMDRF issues PCCP guidance
    Bristol Myers Squibb announced a plan to invest about $2.3 billion in a new manufacturing facility in Houston. The site is expected to expand the company’s production capacity for its pipeline and…
    raps · 1d agoRegulatoryNeutral↗ source
  • Trump administration issues executive order questioning childhood vaccine schedule
    The White House unveiled a new executive order that challenges the established childhood vaccine schedule. President Trump announced the measure from the Oval Office, marking a shift after months o…
    STAT · 18h agoRegulatoryNegative↗ source
  • Sionna’s cystic fibrosis candidate misses primary endpoint in Phase 2 trial, shares plunge
    Sionna Therapeutics announced that its experimental cystic fibrosis drug SION-719 failed to meet the primary endpoint in a Phase 2 trial that added the drug to Vertex Pharmaceuticals' Trikafta. Th…
    BioPharma Dive · 21h agoNegative readoutNegative↗ source
  • FDA rejects ITM-11 radiopharmaceutical over manufacturing flaws, halting rival to Novartis therapy
    The U.S. Food and Drug Administration issued a rejection letter for ITM-11, a radiopharmaceutical therapy developed by ITM Isotope Technologies Munich, citing manufacturing problems that prevent ap…
    STAT · 22h agoRegulatoryNegative↗ source
  • Sanofi faces shortage of two Pompe disease drugs after FDA flags manufacturing issues
    Sanofi has reported a shortage of two medicines used to treat Pompe disease. The shortage emerged after the U.S. Food and Drug Administration issued a warning about manufacturing problems at the co…
    STAT · 1d agoRegulatoryNegative↗ source
  • Tenax Therapeutics’ heart-failure drug misses primary goal in Phase 3 trial, shares tumble
    Tenax Therapeutics announced that its experimental oral levosimendan failed to meet the primary efficacy endpoint in the Phase 3 LEVEL study, which evaluated treatment for a form of heart failure l…
    STAT · 1d agoNegative readoutNegative↗ source