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  • Celcuity waits on FDA review of second plant as cancer drug rollout lags expectations
    Celcuity has announced that it is awaiting the U.S. Food and Drug Administration’s review of a second manufacturing facility needed for its newly approved cancer therapy. The company explained tha…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • Trump administration issues executive order overhauling federal vaccine program, drawing WHO criticism
    President Trump signed an executive order on Monday that reshapes the federal vaccine agenda, proposing changes that officials say lack supporting evidence. The World Health Organization publicly…
    STAT · 2mo agoRegulatoryNegative↗ source
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  • RFK Jr. contrasts vaccine push in D.C. with addiction-treatment focus in California
    In Washington, the health secretary stood beside the president as an executive order was signed to overhaul childhood vaccination policy. The scene highlighted his push for broader vaccine adoption…
    STAT · 2mo agoNeutral↗ source
  • How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and Medicine
    As AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, s…
    BioSpace · 2mo agoRegulatoryNeutral↗ source
  • Experts suggest new safety framework to boost predictability of CNS toxicity assessments
    A recent paper outlines a safety framework intended to make central nervous system (CNS) toxicity predictions more reliable during drug development. The authors argue that new approach methodologi…
    raps · 2mo agoNeutral↗ source
  • Slate Medicines to merge with Fulcrum Therapeutics after Fulcrum drops sickle-cell drug
    Slate Medicines announced it will combine with Fulcrum Therapeutics in a reverse merger, giving the struggling biotech a new corporate home. Fulcrum had been developing pociredir, a therapy design…
    BioPharma Dive · 2mo agoDealNegative↗ source
  • Saudi FDA launches program to accelerate rare-disease drug development
    The Saudi Food and Drug Authority (SFDA) announced a new initiative called the New Accelerator Program for Drugs in Rare Diseases (NADR). The program is designed to speed up the development, evalu…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Paid paternity leave framed as preventive pediatric care in new opinion piece
    Pediatrician Nishant Pandya shares a recent clinic scene where a new father had to return to work the day after his daughter’s birth, highlighting the tension many families face. He notes that whi…
    STAT · 2mo agoPositive↗ source
  • Trump orders MMR vaccine as LSD-targeted drug passes Phase 3 trial
    The latest Endpoints Weekly notes that President Trump placed an order for the measles‑mumps‑rubella (MMR) vaccine. The newsletter also reports that a drug being developed for LSD‑related indicati…
    Endpoints · 2mo agoPositive readoutNeutral↗ source
  • FDA approves Bristol Myers' first oral therapy for advanced multiple myeloma, a new drug class
    The U.S. Food and Drug Administration gave its nod to an oral medication from Bristol Myers Squibb for patients with advanced multiple myeloma. The drug represents the first member of a novel clas…
    STAT · 2mo agoApprovalPositive↗ source
  • FDA clears Bristol Myers' Zenbexus, first drug of a new class for advanced multiple myeloma
    The FDA announced approval of an oral therapy from Bristol Myers Squibb for patients with advanced multiple myeloma. The drug, iberdomide, will be marketed as Zenbexus and is intended to be used t…
    STAT · 2mo agoApprovalPositive↗ source
  • EU regulator withdraws Amgen's Tavneos authorization over serious trial breaches
    European regulators have withdrawn the marketing authorization for Amgen's rare disease drug Tavneos, citing serious breaches in the pivotal clinical trial. The EMA said study staff from ChemoCent…
    BioSpace · 2mo agoRegulatoryNegative↗ source
  • Biotech firm Biogen secures Chinese approval for felzartamab in second-line multiple myeloma
    Biogen announced that its monoclonal antibody felzartamab has received regulatory clearance in China for use in patients with multiple myeloma who have already received first-line therapy. The app…
    Endpoints · 2mo agoApprovalPositive↗ source
  • Capricor shares jump as FDA signals openness to review updated Duchenne therapy
    Capricor Therapeutics saw its stock rise sharply after CEO Linda Marbán told analysts that the FDA is willing to look at an amended filing for its Duchenne muscular dystrophy cell therapy, deramioc…
    BioPharma Dive · 2mo agoRegulatoryPositive↗ source
  • FDA grants accelerated approval to BMS’s iberdomide, branded Zenbexus, as generic competition hits Revlimid and Pomalyst sales
    The FDA has granted accelerated approval to iberdomide, now marketed as Zenbexus, for patients with multiple myeloma who have received at least one prior line of therapy. The drug is to be used in…
    BioSpace · 2mo agoApprovalNeutral↗ source
  • FDA grants accelerated approval to Bristol's Zenbexus for multiple myeloma; PBMs adopt TrumpRx pricing; Novartis wins UK Entresto patent
    The U.S. Food and Drug Administration granted accelerated approval to Bristol Myers Squibb's oral therapy Zenbexus for patients with advanced multiple myeloma. The drug represents a new class of tr…
    STAT · 2mo agoApprovalPositive↗ source
  • FDA grants accelerated approval to Bristol Myers' Zenbexus, first CELMoD for multiple myeloma
    The FDA issued an accelerated approval on Thursday for Zenbexus, a multiple myeloma therapy that Bristol Myers Squibb inherited from its Celgene acquisition. Zenbexus belongs to a new class of pro…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • Capricor Therapeutics sees stock surge as FDA signals openness to extend review of DMD cell therapy
    Capricor Therapeutics' CEO Linda Marbán told investors that the FDA is receptive to adding open label extension data to its Biologics License Application for deramiocel, its Duchenne muscular dystr…
    BioSpace · 2mo agoRegulatoryPositive↗ source
  • Drug-testing lab sues US Pharmacopeia over alleged false statements about testing methods
    Valisure, a laboratory known for testing drug impurities, has filed a lawsuit in a U.S. court accusing the United States Pharmacopeia (USP) of making false and misleading statements about its testi…
    STAT · 2mo agoRegulatoryNegative↗ source
  • New state and federal funding fuels biotech hub growth in Pennsylvania, Kansas City and beyond
    Government programs in Pennsylvania, New York, Kansas City and Central Virginia are pouring new funding into regional biotech hubs as pharma manufacturing investment surges. Matt Gardner, sector p…
    BioPharma Dive · 2mo agoPositive↗ source
  • Industry groups urge FDA to add clarity and flexibility to manufacturer-payor communication guidance
    Industry associations and other stakeholders have asked the U.S. Food and Drug Administration to give more detail and flexibility in its updated guidance on how drug and device makers talk with pay…
    raps · 2mo agoRegulatoryNeutral↗ source
  • FTC launches antitrust probe into Epic Systems over alleged anticompetitive practices
    Federal Trade Commission investigators have reached out to at least three people as part of a broad inquiry into Epic Systems' business practices. Epic, the nation's largest electronic health reco…
    STAT · 2mo agoRegulatoryNegative↗ source
  • Capricor to submit additional data to FDA after negative advisory committee vote on Duchenne therapy
    Capricor Therapeutics announced it will request the FDA to review new data and analyses for its experimental treatment for Duchenne muscular dystrophy. The move follows a recent negative vote from…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • Abcuro raises $66 million to launch Phase 3 trial in muscle-weakening disease after earlier setback
    Abcuro announced it has secured $66 million in financing to support a Phase 3 clinical study targeting a muscle-weakening condition. The funding comes after the company previously reported that it…
    Endpoints · 2mo agoDealNeutral↗ source
  • ICER finds AstraZeneca’s blood pressure pill Baxfendy not cost-effective at $10,950 a year
    ICER released a report saying the clinical benefits of AstraZeneca’s new blood pressure medication Baxfendy do not justify its listed price. The agency noted the drug is priced at $10,950 per pati…
    Endpoints · 2mo agoRegulatoryNegative↗ source