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2,730 stories matching this filter · ← front page

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  • Novartis reports nine cancer cases in patients treated with Zolgensma gene therapy
    Novartis disclosed that nine individuals with spinal muscular atrophy who received its gene therapy Zolgensma later developed tumors. Two of the cases showed evidence that the adeno-associated vir…
    BioPharma Dive · 3d agoRegulatoryNegative↗ source
  • Democrats’ Midterm Win Promises Medicaid Reversal and ACA Subsidy Restoration for Hospitals
    The November midterm election gave Democrats control of both the House and Senate, a result analysts describe as a landslide. The shift is expected to create a more favorable environment for hospit…
    STAT · 3d agoRegulatoryPositive↗ source
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  • New evidence links AAV gene therapies to tumor risk, raising safety concerns
    Recent cases reported this year provide strong evidence that adeno-associated viruses (AAVs), the vectors used to deliver therapeutic genes, can trigger tumor formation. The findings settle a two‑d…
    STAT · 3d agoRegulatoryNegative↗ source
  • Novartis reports seven tumor cases in children treated with Zolgensma
    Novartis has disclosed that seven children who received its gene therapy Zolgensma for spinal muscular atrophy were later found to have tumors. The company said the cases were identified during po…
    STAT · 3d agoRegulatoryNegative↗ source
  • Eli Lilly partners with Hims & Hers to sell Zepbound and Foundayo via telehealth platform
    Eli Lilly announced a partnership with Hims & Hers to make its obesity treatments Zepbound and Foundayo available through the telehealth service. The arrangement lets patients with a prescription…
    BioPharma Dive · 3d agoDealNeutral↗ source
  • Novo Nordisk’s oral Wegovy sales beat forecasts, boosting shares over 5%
    BioPharma Dive’s latest visualization series examines how investors reacted to three drug launches highlighted in recent quarterly earnings. Novo Nordisk reported that its oral Wegovy generated 5.…
    BioPharma Dive · 3d agoPositive readoutPositive↗ source
  • States sue Trump administration to halt Medicaid work-requirement rollout
    Four states filed a lawsuit in the U.S. District Court in Oregon challenging the Trump administration's Medicaid work-requirement changes. The complaint alleges the overhaul would cause sovereign,…
    STAT · 2d agoRegulatoryNegative↗ source
  • Newly elected scientists aim to restore health equity programs cut by Trump administration
    Two newly elected officials with scientific credentials, Michigan Senator-elect Abdul El-Sayed, an epidemiologist, and Georgia Rep-elect Jasmine Clark, a microbiologist, are preparing to join Congr…
    STAT · 2d agoPositive↗ source
  • Amgen’s Repatha linked to fewer heart attacks while Novartis reports seven new tumor cases in Zolgensma patients
    Amgen reported that its cholesterol‑lowering drug Repatha was associated with a lower incidence of heart attacks in a recent analysis. The data suggest the therapy may provide cardiovascular benefi…
    STAT · 3d agoNeutral↗ source
  • Regulators urge risk-based lifecycle approach for AI tools amid election-linked FDA uncertainty
    A panel of regulatory experts at the RAPS AI in Regulatory Conference in Barcelona urged professionals using AI tools to adopt a risk-based, life-cycle perspective rather than focusing solely on va…
    raps · 3d agoRegulatoryNeutral↗ source
  • Podcast examines Democrats' midterm win and concerns over a costly, questionable fertility genetic procedure
    Stat's weekly biotech podcast "The Readout LOUD" released an episode featuring Washington correspondent Daniel Payne to discuss how the Democrats' sweeping midterm victory could shape drug pricing…
    STAT · 3d agoNeutral↗ source
  • MetaVia appoints Sarah Browne as chief medical officer
    MetaVia announced the hiring of Sarah Browne as its new chief medical officer. Browne previously worked as a clinical development consultant for Souffle Therapeutics and before that served as vice…
    STAT · 3d agoPositive↗ source
  • Former MAHA official Calley Means blames White House for yielding to industry pressure
    Calley Means, a leader of the Make America Healthy Again (MAHA) group and former senior official in the Trump administration, announced his resignation and criticized the White House for being sway…
    STAT · 2d agoNegative↗ source
  • Medical records often miss women's health experiences, limiting AI's potential
    Ann Hirsch and Jennifer Silva argue that artificial intelligence cannot reach its full promise in women's health until medical records capture the complete picture of patients' lives. They cite a r…
    STAT · 3d agoNegative↗ source
  • Medicare delays controversial remote patient monitoring ban to 2029, opening window for provider pushback
    Medicare regulators advanced a plan to prohibit hospitals and other providers from using third‑party companies for remote patient monitoring (RPM) services, despite strong opposition from health‑te…
    STAT · 3d agoRegulatoryNeutral↗ source
  • Regulatory experts urge risk-based, lifecycle validation for AI tools in FDA work
    At the RAPS AI in Regulatory Conference in Barcelona, a panel of experts discussed the growing use of AI tools by regulatory professionals. They recommended a risk-based, lifecycle approach to val…
    raps · 3d agoRegulatoryNeutral↗ source
  • Kratom use rises as health officials warn of addiction risk and push emergency bans
    Kratom, a plant‑derived supplement, is becoming more visible in smoke shops and gas stations, yet most Americans remain unfamiliar with the product. Health officials have highlighted the addiction…
    STAT · 3d agoRegulatoryNegative↗ source
  • Opinion: STAT+: What it’s like to live with cognitively unimpaired Alzheimer’s disease
    People with cognitively unimpaired Alzheimer’s “may be asymptomatic, but they do have a disease experience,” writes Jason Karlawish.
    STAT · 3d agoNeutral↗ source
  • Study finds ritual cannabis use in 2,800-year-old Siberian tomb
    Researchers published a paper in Science that presents archaeological evidence of cannabis being used in ritual contexts in a tomb dating back about 2,800 years in Siberia. The analysis of plant re…
    STAT · 3d agoNeutral↗ source
  • FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancer
    The U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
    fda press · 3d agoApprovalPositive↗ source
  • Novartis reports seven new tumor cases in children treated with Zolgensma gene therapy
    Novartis has disclosed that seven children who received its SMA gene therapy, Zolgensma, have been found to have tumors that were not previously reported. The cases were brought to light by an adv…
    STAT · 4d agoRegulatoryNegative↗ source
  • Revolution Medicines reports $198 million Q3 sales for pancreatic cancer drug Rasonque, calling it best oncology launch ever
    Revolution Medicines' new pancreatic cancer drug Rasonque generated $198 million in revenue in the third quarter, far exceeding analyst expectations of $50‑100 million. The drug received FDA appro…
    BioPharma Dive · 4d agoPositive↗ source
  • Revolution Medicines' Rasonque generates $198 million in sales within five weeks of U.S. approval
    Revolution Medicines reported that its pancreatic cancer therapy Rasonque has achieved $198 million in revenue in the first five weeks after receiving U.S. approval. The company said more than 5,00…
    STAT · 4d agoApprovalPositive↗ source
  • Medicare to slash 340B drug payments and expand site-neutral rules in 2027
    Medicare finalized a rule that will cut payments for drugs covered by the 340B discount program and broaden site-neutral payment policies beginning in 2027. The rule is expected to reduce Medicare…
    BioPharma Dive · 4d agoRegulatoryNegative↗ source
  • J&J and AbbVie present early trispecific antibody data for multiple myeloma at ASH meeting
    At the American Society of Hematology (ASH) meeting, Johnson & Johnson and AbbVie are slated to share early clinical data on trispecific antibodies targeting multiple myeloma. These next‑generation…
    BioPharma Dive · 4d agoPositive readoutPositive↗ source