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2,763 stories matching this filter · ← front page

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  • Industry urges FDA to broaden prior-knowledge guidance for gene and cell therapies
    Industry stakeholders have asked the U.S. Food and Drug Administration to expand the scope of its recent draft guidance on scientifically valid prior knowledge for gene therapies that involve genom…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Mass General Brigham drops Dana-Farber from its Medicare Advantage network starting Oct 1
    Mass General Brigham announced that its Medicare Advantage plan will no longer include Dana-Farber Cancer Institute in its provider network beginning October 1, following a recent split between the…
    STAT · 2mo agoRegulatoryNegative↗ source
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  • FDA revisits botanical drug pathway amid ongoing challenges for clozapine and pig kidney research
    The Food and Drug Administration is taking another look at the regulatory pathway for botanical drugs, signaling renewed interest in how plant‑derived therapies can be evaluated and approved. At t…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Disabled workers face higher risk of losing health insurance, report highlights systemic gaps
    The Morning Rounds newsletter reports that disabled employees are more likely to lose their health coverage, underscoring a systemic vulnerability in the U.S. health insurance landscape. The artic…
    STAT · 2mo agoNegative↗ source
  • Lindsay Clancy case highlights risks of fragmented US health care system
    In the months leading up to the tragic deaths of her three children, Lindsay Clancy sought help for worsening mental health from multiple clinicians and two hospitals. She received 13 different med…
    STAT · 2mo agoNegative↗ source
  • FDA lifts clozapine monitoring requirements, easing use for children with schizophrenia
    The Food and Drug Administration on Feb. 24, 2025 eliminated the long‑standing monitoring program that has governed clozapine for more than three decades. The change removes the extensive paperwork…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • 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 · 2mo 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 · 2mo agoApprovalPositive↗ source
  • Scaling CAR-T: The hidden challenge of thousands of patient-specific manufacturing runs
    Legend Biotech and Johnson & Johnson’s Carvykti therapy illustrates the personal connection patients have with CAR-T, but also its unique operating model where each commercial dose is linked to an…
    BioPharma Dive · 2mo agoNeutral↗ 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 · 2mo 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 · 2mo agoApprovalPositive↗ source
  • Ultragenyx to consider major cost cuts after Angelman drug fails trial
    Ultragenyx announced that its experimental therapy GTX-102 (apazunersen) for Angelman syndrome failed to meet primary and secondary endpoints in a Phase 3 study. The company said there were no dif…
    BioPharma Dive · 2mo agoNegative readoutNegative↗ source
  • Superluminal Medicines raises $60 million to advance AI-designed MC4R drug for rare obesity forms
    Superluminal Medicines, an AI-driven drug discovery startup, announced a $60 million financing round aimed at moving its first candidate toward clinical testing. The candidate targets the MC4R G p…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • GSK to spend up to $1.3 billion on Hutchmed's dual-target cancer therapy
    GSK announced a deal to acquire the majority rights to Hutchmed's experimental therapy HMPL-A830. The agreement includes an upfront payment of $110 million and potential milestone and royalty payme…
    BioPharma Dive · 2mo 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 · 2mo agoDealNeutral↗ 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 · 2mo agoNegative readoutNegative↗ source
  • Akeso's ivonescimab shows survival advantage over Keytruda in Chinese lung cancer trial
    A new data cut from a study comparing ivonescimab, a bispecific antibody from China-based Akeso, with Merck's Keytruda in patients with non-small cell lung cancer was released. The interim results…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ 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 · 2mo 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 · 2mo agoDealNegative↗ 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 · 2mo agoNeutral↗ source
  • CBER official overturns Replimune melanoma drug rejection; AbbVie reports phase 3 success in multiple myeloma
    A CBER regulator has reversed a prior decision to reject Replimune's experimental melanoma therapy, allowing the program to move forward. AbbVie announced that its multiple myeloma candidate achie…
    raps · 2mo agoRegulatoryNeutral↗ 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 · 2mo 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 · 2mo 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 · 2mo agoRegulatoryNeutral↗ source
  • Industry urges FDA to broaden prior-knowledge guidance for gene and cell therapies
    Industry groups have asked the U.S. Food and Drug Administration to broaden its draft guidance on the use of scientifically valid prior knowledge in developing gene therapies that involve genome ed…
    raps · 2mo agoRegulatoryNeutral↗ source