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1,617 stories matching this filter · ← front page

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  • 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 · 1h 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    European regulators have withdrawn the marketing authorization for Amgen's rare disease drug Tavneos, citing serious breaches in the pivotal clinical trial.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 · 2h agoRegulatoryNegative↗ source
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  • 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 · 2h 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 · 32m agoRegulatoryNegative↗ 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 · 9h 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 · 5h 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 · 9h agoPositive↗ 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 · 5h 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 · 5h 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 · 5h agoNegative↗ 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 · 23h 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
  • 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
  • California distributes over 120,000 low-cost insulin glargine packs as Novo Nordisk CEO warns investors on obesity drug differentiation
    California's state health program has been distributing a low-cost insulin glargine product, more than 120,000 five-pen packs since its launch seven months ago. Each pack is priced at $55, which i…
    STAT · 1d agoNeutral↗ source
  • Zealand Pharma sells rights to rare blood cancer drug rusfertide for up to $100M
    Zealand Pharma entered a royalty purchase and sale agreement with Royalty Pharma, receiving $50 million upfront and the possibility of an additional $50 million after one year. In exchange, Zealan…
    BioSpace · 1d agoDealNeutral↗ source
  • PDS Biotechnology pauses phase 3 head-and-neck trial to prioritize colorectal cancer immunotherapy
    PDS Biotechnology announced it is stopping work on its phase 3 head and neck cancer therapy, Versamune HPV (PDS0101), in order to reallocate resources to a different drug program. The halted trial…
    Fierce Biotech · 1d agoNeutral↗ source
  • Oxford study offers model showing statins pose minimal muscle disorder risk, a tool against health misinformation
    The piece highlights how fearmongering about statins has surged online, with claims that the drugs damage the brain, liver and muscles. The authors argue that clearer evidence at the point of claim…
    STAT · 1d agoPositive↗ source
  • Vaccines protect lives: A physician’s reminder of what we lose without them
    Dr. Krutika Kuppalli, an infectious-disease physician and former WHO medical officer, reflects on her frontline work where vaccines were scarce. In Haiti she witnessed a patient die from tetanus,…
    STAT · 1d agoPositive↗ source
  • Medicare's new add-on payments for AI devices may spur hospital adoption and risk overuse
    Medicare has begun paying hospitals extra fees for using newly authorized AI-based medical devices, known as technology add-on payments, for a limited period after market entry. The payments are i…
    STAT · 1d agoRegulatoryNeutral↗ source
  • PTC Therapeutics acquires Sangamo’s Fabry gene therapy program for $111 million upfront
    PTC Therapeutics announced it has purchased the Fabry disease gene-therapy program (ST-920) from Sangamo Therapeutics. The deal provides $111 million in upfront cash and includes up to $100 millio…
    Fierce Biotech · 1d agoDealPositive↗ source
  • July biopharma layoffs down 94% YoY, 466 jobs cut across six companies
    July saw a sharp decline in biopharma workforce reductions, with only 466 employees affected, a 94% drop compared with the same month last year. BioSpace data shows six companies announced or proj…
    BioSpace · 1d agoLayoffsNegative↗ source
  • Versa Vascular appoints former Medtronic heart franchise leader Bill Shields as CEO
    Bill Shields, who spent 15 years leading Medtronic’s structural heart franchise, is leaving the medtech giant to become chief executive of Versa Vascular, a startup developing tricuspid valve repai…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Eli Lilly moves to curb black-market sales of retatrutide amid rising illicit demand
    Eli Lilly announced steps to address the growing black‑market trade of its obesity/diabetes drug retatrutide, which has seen increasing illicit use. The company is working with law‑enforcement and…
    STAT · 23h agoRegulatoryNegative↗ source
  • New fertility options give young cancer survivors hope for parenthood
    Young cancer patients are facing increasing concerns about future fertility, prompting the growth of a specialty called oncofertility that blends oncology and reproductive medicine. One patient, J…
    STAT · 1d agoPositive↗ source
  • Avalyn Pharma CEO shares personal moment as company prepares for Nasdaq IPO
    Avalyn Pharma and Generate Biomedicines executives talked about the long hours and challenges of preparing their companies for an initial public offering. Avalyn CEO Lyn Baranowski highlighted a m…
    BioSpace · 1d agoPositive↗ source