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2,651 stories matching this filter · ← front page

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  • 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 · 9d 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 · 10d agoRegulatoryNegative↗ source
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  • 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 · 10d 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 · 10d agoRegulatoryNegative↗ source
  • Methadone clinics show mixed progress two years after regulatory overhaul
    In 2024 the federal government revised rules for opioid addiction treatment centers, giving them more leeway to provide take‑home methadone doses and removing the requirement that patients attend c…
    STAT · 10d agoRegulatoryNeutral↗ source
  • Overseas MDMA and psilocybin makers eye U.S. market as regulatory landscape eases
    Companies that produce MDMA and psilocybin for patients abroad are turning their attention to the United States, hoping to leverage experience gained under more permissive foreign rules. Rising pol…
    BioSpace · 10d agoPositive↗ source
  • UnitedHealthcare CEO Brian Thompson killed; suspect Luigi Mangione pleads guilty to federal stalking
    Luigi Mangione, 28, pleaded guilty in Manhattan federal court to stalking charges tied to the 2024 killing of UnitedHealthcare chief executive Brian Thompson. He told the court he followed Thompso…
    STAT · 10d agoNegative↗ source
  • Redx Pharma pursues new reverse merger with Skye after 2023 setback
    Redx Pharma, a UK biotech focused on ROCK inhibitor therapies for fibrosis, is seeking a reverse merger with Skye to obtain a Nasdaq listing. The company previously attempted a similar transaction…
    Endpoints · 10d agoDealNeutral↗ source
  • Bicara appoints President Ryan Cohlhepp as CEO effective Jan. 1, while J&J veteran John Reed joins Madrigal board
    Bicara Therapeutics announced a leadership transition, naming its current President and COO Ryan Cohlhepp as the new chief executive officer effective Jan. 1. Cohlhepp will take over the role as t…
    Endpoints · 10d agoNeutral↗ source
  • Cytokinetics sues Bristol Myers Squibb over recently granted patent, intensifying rivalry
    Cytokinetics has filed a lawsuit against Bristol Myers Squibb, seeking to invalidate a patent that was recently granted to the latter. The legal action adds a courtroom dimension to an already com…
    Endpoints · 10d agoCRLNegative↗ source
  • MapLight Therapeutics pauses early‑stage programs to focus on lead schizophrenia and Alzheimer’s psychosis candidate
    MapLight Therapeutics announced it is pausing its preclinical and discovery activities. The company said it will redirect resources toward advancing its lead candidate, ML-007C-MA, which is being d…
    Endpoints · 10d agoNeutral↗ source
  • BioCryst to rely on external partnerships after ending internal discovery programs
    BioCryst Pharmaceuticals CEO Charlie Gayer told Fierce that the company remains committed to science and research even as it shuts down its internal discovery efforts. Earlier this year the firm’s…
    Fierce Biotech · 10d agoNeutral↗ source
  • US and UK health systems both prioritize clinical care over community prevention, author warns
    Kyle Vanelli argues that the United States and United Kingdom health systems share a fundamental flaw: they default to biomedical, hospital-based interventions rather than community-based preventiv…
    STAT · 10d agoNegative↗ source
  • CMS rule blocks Medicaid funding for pediatric gender-affirming care, raising legal challenges
    The Centers for Medicare and Medicaid Services finalized a rule that prohibits the use of Medicaid and CHIP dollars to cover pediatric gender‑affirming medications and surgeries. Previous attempts…
    STAT · 10d agoRegulatoryNeutral↗ source
  • Pediatricians push back against vaccine fear-mongering by federal leaders
    Andrew D. Racine, president of the American Academy of Pediatrics, writes an opinion piece warning that federal leaders are spreading misleading claims about vaccines, creating confusion for parent…
    STAT · 10d agoNegative↗ source
  • Formation Bio appoints Michael Ehlers as chief scientific officer and head of R&D
    Formation Bio announced the hiring of Michael Ehlers as its new chief scientific officer and head of research and development. Ehlers brings experience from founding and leading Ascidian Therapeut…
    STAT · 10d agoPositive↗ source
  • Opinion: Car telematics warns of health-insurance data surveillance
    Sociologists Andréa Becker and Paul Kamuf argue that the telematics model used in auto insurance could become a template for health‑insurance data collection. They describe how drivers’ minute‑by‑…
    STAT · 10d agoNegative↗ source
  • FDA grants accelerated approval to Bristol Myers' iberdomide for relapsed or refractory multiple myeloma
    The U.S. Food and Drug Administration has issued an accelerated approval for iberdomide, a small-molecule therapy developed by Bristol Myers Squibb. The approval targets patients with multiple mye…
    Endpoints · 10d agoApprovalPositive↗ source
  • Taiho and Cullinan report positive Phase 3 results for zipalertinib in EGFR exon 20 insertion lung cancer
    Taiho Oncology and Cullinan Therapeutics announced that their experimental drug zipalertinib achieved positive results in a Phase 3 trial for first‑line treatment of lung cancer patients whose tumo…
    BioPharma Dive · 11d agoPositive readoutPositive↗ source
  • Taiho and Cullinan’s zipalertinib shows progression‑free survival benefit in Phase 3 NSCLC trial
    Taiho Pharmaceutical and Cullinan Therapeutics reported that their EGFR inhibitor zipalertinib, combined with chemotherapy, significantly extended progression‑free survival for patients with advanc…
    BioSpace · 11d agoPositive readoutPositive↗ source
  • Neurocrine’s rare-disease drug approved but later linked to deaths and serious side effects
    Neurocrine Biosciences received regulatory approval for a rare‑disease therapy after a small clinical trial showed modest efficacy and side effects that were considered manageable. The decision was…
    STAT · 11d agoRegulatoryNegative↗ source
  • Taiho and Cullinan's zipalertinib clears Phase 3 trial in EGFR-mutated lung cancer
    Taiho Oncology and Cullinan Therapeutics announced that their oral EGFR inhibitor zipalertinib successfully completed a registrational Phase 3 study in patients with a specific genetic form of lung…
    Endpoints · 11d agoPositive readoutPositive↗ source
  • European regulators withdraw Amgen's Tavneos over questionable data
    European regulators announced they are pulling Amgen's rare disease drug Tavneos from the European market after reviewing data they deemed incorrect and misleading. The authorities said the data s…
    Endpoints · 11d agoRegulatoryNegative↗ source
  • Bankrupt Sangamo sells Fabry gene therapy to PTC and prion program to Lilly for $161M
    Sangamo Therapeutics, currently in Chapter 11 bankruptcy, has agreed to divest its Fabry disease gene therapy and several other platforms to raise cash for the restructuring. PTC Therapeutics emer…
    BioSpace · 11d agoDealNeutral↗ source
  • FDA's PDUFA VIII adds 'America First' incentives and speeds up drug reviews
    The Food and Drug Administration announced the next five‑year reauthorization of the Prescription Drug User Fee Act, known as PDUFA VIII. The agency said the new framework will introduce several po…
    Endpoints · 11d agoRegulatoryPositive↗ source