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2,249 stories matching this filter · ← front page

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  • 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 · 1h agoRegulatoryNeutral↗ 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 · 1h agoNegative↗ source
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  • 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 · 1h agoNegative↗ source
  • How will legal challenges fare against CMS rule on gender-affirming care?
    A CMS rule finalized this week may prove more difficult to challenge than previous Trump administration actions to end transgender care for young people.
    STAT · 1h ago↗ source
  • MapLight dims preclinical programs to make phase 3-ready schizophrenia drug shine brighter
    Despite mixed results for its experimental schizophrenia treatment last month, MapLight Therapeutics is going all-in on the asset—at the expense of its preclinical programs.
    Fierce Biotech · 5h 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 · 13h 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 · 18h 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 · 23h 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 · 23h 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 · 15h agoRegulatoryNegative↗ 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 · 16h 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 · 19h agoDealNeutral↗ source
  • Karyopharm faces default risk with only a month left to rescue cancer expansion
    Karyopharm Therapeutics, a commercial-stage cancer drugmaker, is confronting severe financial strain as its market capitalization is roughly one‑third of the revenue it expects to generate in 2026.…
    Endpoints · 19h agoNegative↗ source
  • Khartis Therapeutics secures $50 million Series B funding from Forge Life Science Partners, Longwood Fund and Lilly Asia Ventures
    San Diego-based Khartis Therapeutics announced a $50 million Series B financing round. The round was led by Forge Life Science Partners and included participation from Longwood Fund, Lilly Asia Ve…
    Endpoints · 20h agoDealPositive↗ 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 · 21h agoNeutral↗ source
  • PTC Therapeutics and Eli Lilly to acquire parts of bankrupt Sangamo for up to $264 million
    The gene-editing company Sangamo Therapeutics has filed for bankruptcy, placing its assets up for sale. An auction process has identified two bidders: PTC Therapeutics and Eli Lilly, which togethe…
    Endpoints · 23h 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
  • 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 · 19h agoRegulatoryNegative↗ source
  • Aligned Marketplace secures $20 million to link self-insured employers with primary-care clinics
    Aligned Marketplace is a health‑tech startup that matches self‑insured employers with primary‑care clinics, helping companies provide direct access to medical services for their workers. The compa…
    Endpoints · 21h agoDealPositive↗ 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