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2,427 stories matching this filter · ← front page

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  • 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 · 1h 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 · 3h agoApprovalPositive↗ source
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  • 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    European regulators have withdrawn the marketing authorization for Amgen's rare disease drug Tavneos, citing serious breaches in the pivotal clinical trial.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 · 3h agoRegulatoryNegative↗ 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 · 3h agoApprovalNeutral↗ 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 · 1h 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 · 4h agoPositive↗ source
  • Capricor plans FDA amendment after advisory committee rejects cardiomyopathy endpoint, stock jumps
    Capricor Therapeutics received a negative vote from an FDA advisory committee on the efficacy of its cell therapy, deramiocel, for treating cardiomyopathy in Duchenne muscular dystrophy. The nine‑t…
    Fierce Biotech · 5h agoRegulatoryPositive↗ source
  • MapLight shifts focus to schizophrenia drug after mixed Phase 2 results, raises $150 million
    MapLight Therapeutics reported mixed outcomes from its Phase 2 Zephyr trial of the muscarinic agonist ML-007C-MA. A twice‑daily dose achieved the study’s primary endpoint with notable reductions in…
    Fierce Biotech · 10h agoDealNeutral↗ 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 · 6h 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 · 11h agoPositive↗ 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 · 4h agoNeutral↗ 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 · 1h 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 · 6h 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 · 6h agoRegulatoryNeutral↗ 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 · 6h agoNegative↗ source
  • ‘We’re not afraid of competition’: BioCryst CEO sets out strategy after scrapping internal discovery
    BioCryst CEO Charlie Gayer told Fierce the company is “not getting away from science and R&D” despite shutting down its internal discovery efforts.
    Fierce Biotech · 4h ago↗ 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 · 17h 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 · 23h 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 · 1d 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 · 1d 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 · 1d 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 · 20h 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 · 1d 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 · 21h agoRegulatoryPositive↗ source
  • PTC Therapeutics agrees to pay up to $211 million for Sangamo’s experimental Fabry disease gene therapy
    PTC Therapeutics announced it will invest up to $211 million to acquire rights to an advanced gene therapy for Fabry disease being developed by Sangamo Therapeutics. The therapy, called ST-920 (is…
    BioPharma Dive · 1d agoDealNeutral↗ source