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  • CDC-Pennsylvania dispute over measles death counts fuels drama amid rising cases
    Former CDC officials warn that a clash with Pennsylvania over how measles deaths are counted is creating unnecessary drama while cases surge. They explain that states normally follow a standardize…
    STAT · 9d agoRegulatoryNegative↗ source
  • FDA approves Zanvastro, first therapy targeting protein buildup in Alexander disease
    The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in both pediatric and adult patients. Zanvastro is the first FDA-approve…
    fda press · 9d agoApprovalPositive↗ source
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  • Akeso and Summit report ivonescimab meets overall survival endpoint in Phase 3 lung cancer trial
    Akeso and its partner Summit said the Phase 3 trial of ivonescimab, a PD-1xVEGF bispecific antibody, has met its overall survival endpoint in a selected group of lung cancer patients. The announcem…
    Endpoints · 9d agoPositive readoutPositive↗ source
  • AbbVie reports 60% reduction in progression risk for myeloma drug etentamig in Phase 3 trial
    AbbVie announced results from a Phase 3 study of its T cell engager etentamig in patients with multiple myeloma. The trial demonstrated a 60% relative reduction in the risk of disease progression…
    Endpoints · 9d agoPositive readoutPositive↗ source
  • Gene-edited pig kidneys enable patients to go months without dialysis before receiving human transplants
    Doctors at eGenesis reported that two patients who received genetically engineered pig kidneys were later able to receive human donor kidneys after a period on dialysis. The transition was not seam…
    STAT · 9d agoPositive↗ source
  • Ionis secures FDA approval for Zanvastro, first disease-modifying therapy for rare Alexander disease
    Ionis Pharmaceuticals announced that the U.S. Food and Drug Administration has approved Zanvastro, marking the first disease-modifying treatment for Alexander disease, a rare and often fatal neurol…
    STAT · 9d agoApprovalPositive↗ source
  • GSK licenses Hutchmed's KRAS-EGFR antibody-drug conjugate for $110 million upfront
    GSK announced it will pay $110 million upfront to obtain a license for a KRAS-EGFR antibody-drug conjugate developed by Chinese biopharma Hutchmed. The agreement also includes potential milestone p…
    Endpoints · 9d agoDealPositive↗ source
  • FDA alerts hospitals to purge cassette fault in Abiomed Impella controllers
    The FDA issued an Early Alert after identifying a problem with the purge cassette recognition in Abiomed’s Automated Impella Controllers, which could cause prolonged delays in mechanical circulator…
    fda medwatch · 10d agoRegulatoryNegative↗ source
  • Merck's dealmaker warns of increased M&A activity as Keytruda patent expires
    Merck's chief M&A officer says the company expects a surge in deal flow as the patent for its flagship immunotherapy, Keytruda, approaches expiration. The leadership has been pursuing acquisitions…
    Endpoints · 9d agoDealNeutral↗ source
  • Seattle researchers unveil $95 million AI biology initiative to map nature’s design rules
    Seattle scientists have announced a new $95 million effort that uses artificial intelligence to decode the design principles of biological molecules. The project, led by Nobel laureate David Baker,…
    STAT · 9d agoDealNeutral↗ source
  • Health tech investors shift focus to larger funding rounds, Cityblock secures $116 million
    Throughout the past year, investors in digital health have increasingly favored megafunding rounds rather than smaller seed or Series A deals. In August, community-health startup Cityblock announc…
    Endpoints · 9d agoDealPositive↗ source
  • Ultragenyx gene therapy for Angelman syndrome fails Phase 3 trial, company to cut expenses
    An experimental gene therapy targeting Angelman syndrome did not meet its primary endpoint in a Phase 3 study, according to Ultragenyx. The trial showed no difference between the therapy, GTX-102,…
    STAT · 9d agoNegative readoutNegative↗ source
  • FDA requests public input to accelerate botanical drug product development
    The U.S. Food and Drug Administration issued a request for information (RFI) to collect public comments on ways to move botanical drug products forward. Botanical drug products are derived from pl…
    fda press · 9d agoRegulatoryNeutral↗ source
  • Abivax remains independent despite intense acquisition speculation
    Biotech merger activity is at record levels, yet the French company Abivax, which is developing the ulcerative colitis drug obefazimod, has not been bought. Rumors have floated about a potential $…
    STAT · 9d agoDealNegative↗ source
  • Superluminal Medicines raises $60M Series B to launch Phase 1 trial of genetic obesity therapy
    Superluminal Medicines, a Boston‑based biotech, announced it has closed a $60 million Series B financing round. The capital will fund the company’s first‑in‑human study of its genetic obesity candi…
    Endpoints · 9d agoDealNeutral↗ source
  • Overdose deaths fall sharply in US and abroad, report links decline to naloxone and harm-reduction measures
    A new report highlights a sudden drop in drug overdose deaths after years of consistently high numbers in the United States. The data show that U.S. deaths fell 27% in 2024 and preliminary figures…
    STAT · 10d agoNeutral↗ source
  • Boston Scientific recalls Infinion CX spinal cord stimulator leads over risk of mechanical stress and fracture
    Boston Scientific issued a recall of its Infinion CX spinal cord stimulator leads after identifying a risk of mechanical stress at the anchor site that can cause high impedance readings or lead fra…
    fda medwatch · 10d agoCRLNegative↗ source
  • FDA issues early alert on Draeger VentStar Resus Neo hoses due to crack risk and potential ventilation failure
    The FDA’s Center for Devices and Radiological Health has released an early alert about a potential high risk issue with Draeger’s VentStar Resus Neo breathing circuit hoses. The alert follows a let…
    fda medwatch · 10d agoRegulatoryNegative↗ source
  • Ultragenyx's Angelman syndrome drug fails Phase 3 trial, halting development
    Ultragenyx reported that its experimental antisense oligonucleotide designed for Angelman syndrome did not meet primary endpoints in a Phase 3 study. The trial, which enrolled patients with the ra…
    Endpoints · 10d agoNegative readoutNegative↗ source
  • FDA grants emergency use authorization for Capstar and generic nitenpyram to prevent and treat New World screwworm in dogs and cats
    The U.S. Food and Drug Administration issued an Emergency Use Authorization for Capstar (nitenpyram) tablets and updated the EUA for the generic Nitenpyram Tablets. Both products are now authorized…
    fda press · 9d agoRegulatoryPositive↗ source
  • FDA’s Biologics Branch Scores Wins Against Unproven Stem Cell Clinics, Says Expert
    Professor Paul Knoepfler, a cell‑biology professor at UC Davis, writes that the FDA’s biologics division has recently taken concrete steps to curb the proliferation of unproven stem‑cell clinics in…
    STAT · 10d agoRegulatoryPositive↗ source
  • FDA launches TEMPO pilot to let generative AI medical devices reach patients before formal approval
    The Food and Drug Administration has opened a new pilot program called TEMPO that permits certain generative‑AI medical devices to be made available to patients even though they have not received f…
    STAT · 10d agoRegulatoryNeutral↗ source
  • New cardiovascular guidelines released for tactical athletes such as EMTs, firefighters and police
    The American College of Cardiology and the American Heart Association issued new cardiovascular guidance aimed at clinicians who treat "tactical athletes," a term that includes emergency responders…
    STAT · 9d agoRegulatoryPositive↗ source
  • Pfizer grants Medicus co-development rights to CD228-targeted ADC PF-08046031
    Pfizer announced it is transferring co-development rights for its CD228-targeted antibody-drug conjugate, PF-08046031, to Medicus Pharma. The ADC, originally discovered by Seagen, will now be adva…
    Endpoints · 9d agoDealNeutral↗ source
  • OpenEvidence introduces new family of AI models for health tech
    OpenEvidence announced a new family of artificial intelligence models aimed at health technology applications, as reported in STAT's Health Tech newsletter. The announcement highlights the company'…
    STAT · 9d agoPositive↗ source