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  • Convenience Kit Correction: Becton Dickinson Issues Correction for Kits and Procedure Trays Containing Recalled Sodium Chloride Ampules
    BD is correcting convenience kits and procedural trays containing recalled Huons Co. sodium chloride ampules
    fda medwatch · 28d ago↗ source
  • FDA nominee Heidi Overton pledges faster drug trials to keep US biotech competitive
    Heidi Overton, President Trump's nominee for FDA commissioner, will appear before a Senate committee to outline her priorities for the agency. She said the administration wants her to 'go fast,' a…
    STAT · 28d agoRegulatoryPositive↗ source
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FDA panel questions effectiveness of Grail's early-cancer detection test
FDA's Molecular and Clinical Genetics Panel and agency officials raised concerns about Grail's next-generation sequencing test designed to detect multiple cancers early in adults over 50. The advi…
Endpoints · 28d agoRegulatoryNegative↗ source
  • World's first personalized gene-editing therapy costs $1.65 million per patient, project director says
    At a rare disease conference in Oxford, Fyodor Urnov disclosed that the world's first therapy designed to correct an individual’s unique genetic mutation cost $1.65 million to produce. The treatme…
    Endpoints · 28d agoNeutral↗ source
  • FDA issues early alert on React Health VOCSN ventilators over connector fault
    The FDA's Center for Devices and Radiological Health has posted an early alert about a potential high‑risk problem with certain VOCSN ventilator units made by Ventec Life Systems, operating as Reac…
    fda medwatch · 29d agoRegulatoryNeutral↗ source
  • FDA advisory panel backs Grail's Galleri multi-cancer blood test, citing benefits outweigh risks
    The Food and Drug Administration’s advisory committee voted to endorse Galleri, a blood test from Grail that screens for multiple cancers, saying the benefits outweigh the risks. The panel’s vote…
    STAT · 28d agoRegulatoryPositive↗ source
  • Former Changsheng biotech chair sentenced to life in prison over Chinese rabies vaccine scandal
    Chinese authorities sentenced Gao Junfang, the former chairwoman of Changsheng Biotechnology, to life imprisonment after a court found her guilty of wrongdoing in a rabies vaccine scandal. The cas…
    Endpoints · 28d agoRegulatoryNegative↗ source
  • Enveda secures $311 million in third consecutive megaround to advance discovery and weight-maintenance programs
    Enveda, a biotech startup operating out of Colorado and India, announced a new financing round on September 23, 2026. The company raised $311 million, marking its third large-scale funding round i…
    Endpoints · 28d agoDealPositive↗ source
  • Flagship Pioneering secures Pentagon contract to develop biological threat countermeasures
    Flagship Pioneering, a biotech investment firm, has been awarded a contract by the U.S. Department of Defense. The contract aims to advance technologies that can serve as countermeasures against b…
    STAT · 28d agoDealPositive↗ source
  • AI startup Basecamp Research secures $140 million Series C funding and outlines six-program AI pipeline
    Basecamp Research, an AI-driven biotech founded in 2019, announced a $140 million Series C financing round. The company said the new capital will support its ambitious six-program pipeline that ap…
    Endpoints · 28d agoDealPositive↗ source
  • US HHS and FDA announce new rules to expand non-animal testing methods as legal battles over youth gender-affirming care continue
    The legal landscape for youth gender‑affirming care remains turbulent, with the Trump administration's aggressive stance prompting dozens of hospitals nationwide to halt such services, even in the…
    STAT · 28d agoRegulatoryNeutral↗ source
  • Roche reports positive interim Phase 3 results for kidney drug, paving way for accelerated approval
    Roche announced interim results from its Phase 3 trial of a kidney disease therapy, indicating the study met its primary endpoints. The data, released on Wednesday, suggest the drug could qualify…
    Endpoints · 28d agoPositive readoutPositive↗ source
  • FDA shift sparks renewed pharma and VC focus on osteoporosis drug development
    The FDA recently altered its regulatory framework for osteoporosis medicines, prompting a wave of renewed interest across the pharmaceutical sector. Earlier, drugs from Eli Lilly, Merck, Novartis…
    STAT · 28d agoRegulatoryPositive↗ source
  • Insurers UnitedHealth, CVS, and Kaiser oppose Medicare's contractor ban on remote patient monitoring
    Major insurers including UnitedHealth Group, CVS Health and Kaiser Permanente have formally objected to a new Medicare proposal that would change billing for remote patient monitoring (RPM). The p…
    STAT · 28d agoRegulatoryNeutral↗ source
  • FDA issues early alert on Abiomed Impella controller safety issue
    The FDA Center for Devices and Radiological Health (CDRH) has posted an Early Alert about a potential high risk problem with certain Abiomed Impella automated controllers. Abiomed has sent a lette…
    fda medwatch · 29d agoRegulatoryNegative↗ source
  • White House plan to tighten control over NIH grants stalls after bipartisan opposition
    A proposed executive order that would have given the White House significant authority over National Institutes of Health grant awards is now considered dead. The plan called for a commission of p…
    STAT · 28d agoRegulatoryNeutral↗ source
  • Roivant's FcRn drug IMVT-1402 fails Phase 2b lupus trial
    Roivant announced that its FcRn-targeting antibody IMVT-1402 (imeroprubart) failed to meet primary endpoints in a Phase 2b trial in patients with lupus. The study did not show improvement in disea…
    Endpoints · 28d agoNegative readoutNegative↗ source
  • Family’s struggle to receive cystic fibrosis medication highlights care gaps
    Stephanie Marquart in Knoxville, Tennessee, waited anxiously for a delivery to her home, refreshing the tracking page repeatedly as the package made its way to her doorstep. The episode, described…
    Endpoints · 28d agoNegative↗ source
  • Industry groups back FDA’s proposed distributed manufacturing rule, seek clarification on implementation
    Industry trade groups have expressed overall support for the FDA’s draft rule that would allow drugs to be produced using distributed manufacturing models. The proposal aims to modernize the supply…
    raps · 29d agoRegulatoryNeutral↗ source
  • US to End Personal Medication Import Loophole as New Customs Rule Takes Effect
    A new regulation will begin next month that ends the longstanding loophole allowing Americans to import prescription drugs by mail. The rule, reported by the Wall Street Journal, requires any medic…
    STAT · 28d agoRegulatoryNeutral↗ source
  • Quorum Health moves to nonprofit status as its rural hospital chain faces insolvency
    Quorum Health, a chain of mostly rural hospitals owned by private-equity investors, is in the process of converting all 11 of its facilities to nonprofit status after years of financial strain that…
    STAT · 28d agoRegulatoryNegative↗ source
  • Berlin Seeds recalls 950 lbs of alfalfa sprouting seed over possible STEC and Salmonella contamination
    Berlin Seeds of Millersburg, Ohio announced a recall of 950 pounds of its alfalfa sprouting seed. The recall was triggered because the seed could be contaminated with Shiga toxin‑producing Escheri…
    fda recalls · 28d agoRegulatoryNegative↗ source
  • STAT AI Prognosis newsletter tackles AI doomerism and offers guidance for health professionals
    The latest web edition of STAT’s AI Prognosis newsletter, authored by health tech reporter Brittany Trang, focuses on the growing chatter around AI doomerism. It aims to help readers cut through th…
    STAT · 28d agoNeutral↗ source
  • Opinion: Mentally ill women need stronger support to become mothers
    Meg LeDuc writes in an opinion piece that maternal mental-health needs of women with serious psychiatric conditions have been largely ignored in the United States. She recounts her own history of…
    STAT · 28d agoPositive↗ source
  • Amgen reports positive Phase 3 results for Sjögren's drug; Novartis announces $900M radioligand partnership
    Amgen said its CD40 ligand antagonist dazodalibep met the primary endpoint in a Phase 3 trial for Sjögren's syndrome, marking a notable achievement for the company. Novartis disclosed a $900 milli…
    Endpoints · 29d agoPositive readoutPositive↗ source