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658 stories matching this filter · ← front page

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  • FDA sends warning letters to Sanofi and Viatris over misleading product claims
    The FDA’s Office of Prescription Drug Promotion issued untitled warning letters to Sanofi and Viatris after reviewing promotional materials that the agency deemed misleading. The letters cite spec…
    raps · 1mo agoRegulatoryNegative↗ source
  • Summit Therapeutics' ivonescimab shows improved survival trend in extended follow-up, easing investor doubts
    A new analysis of Summit Therapeutics and Akeso's dual‑acting cancer immunotherapy ivonescimab indicates that the drug's impact on overall survival has grown with longer observation. The extended d…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
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Psychiatry & CNS724
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Infectious Disease357
  • MDCG: Only manufacturers should assign UDI-DIs
    The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better…
    raps · 1mo agoNeutral↗ source
  • Novartis beats sales expectations as Q2 revenue rises to $14.4B, eyes upcoming study readouts
    Novartis reported a modest rise in second‑quarter sales, lifting its share price after the company posted a 1% increase in net sales to $14.4 billion, surpassing analyst forecasts for a decline. A…
    BioPharma Dive · 1mo agoEarningsPositive↗ source
  • Novo Nordisk sues Eli Lilly over alleged misleading obesity drug ads
    Novo Nordisk filed a lawsuit in a New Jersey federal court accusing Eli Lilly of deceptive advertising for its GLP-1 obesity medicines. The action follows a cease-and-desist request that asked Lil…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • Agios halts development of sickle cell drug tebapivat after mid-stage trial failure
    Agios announced it will stop developing tebapivat for sickle cell disease after a mid-stage trial did not meet expectations. The drug, a next-generation pyruvate kinase activator related to the ap…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • FDA issues warning letters for CGMP breaches and inadequate trial consent, EU releases AI transparency guidelines
    The U.S. Food and Drug Administration sent warning letters to several drug manufacturers for not meeting current good manufacturing practice requirements. One firm was also cited for failing to pr…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Dimension raises $800 million for third fund to boost AI-driven biotech ventures
    Dimension, a venture capital firm focused on the intersection of technology and biotech, announced the closing of its largest fund to date, raising $800 million for its third fund, called Dimension…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • EU releases AI Act transparency guidelines, impacting healthcare AI developers
    The European Commission published new guidelines on Monday to help providers and deployers of AI systems meet the transparency obligations set out in the EU AI Act. The guidance includes examples…
    raps · 1mo agoRegulatoryNeutral↗ source
  • EU releases AI Act transparency guidelines, affecting health-tech developers
    The European Commission has published new guidelines to help providers and users of artificial intelligence systems meet the transparency obligations set out in the EU AI Act. The document explain…
    raps · 1mo agoRegulatoryNeutral↗ source
  • PT Organics recalls select Pumpkin Tree banana‑strawberry puree pouches over possible soft plastic contamination
    PT Organics Limited of Lake Oswego, Oregon announced a voluntary recall of certain Pumpkin Tree Peter Rabbit Organics Banana & Strawberry Fruit Puree pouches. The recall is due to an internal pack…
    fda recalls · 1mo agoCRLNeutral↗ source
  • Fresh & Ready Foods recalls Spicy Breakfast Burritos over undeclared soy
    Fresh & Ready Foods LLC announced a recall of its Sprig & Sprout and Fresh and Ready Spicy Breakfast Burritos because they may contain undeclared soy. The problem was traced to inadvertent inclusi…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Tempus AI to buy cancer test maker Personalis for $1.5 billion
    Tempus AI announced it will acquire Personalis, a California-based company that offers a molecular residual disease test for cancer, in a transaction valued at $1.5 billion. The deal, priced at $1…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • UK regulator reports rise in drug approvals and new AI healthcare regulations
    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) released its 2025-2026 annual report to Parliament. The agency highlighted that it approved more new medicines in the past year…
    raps · 1mo agoRegulatoryPositive↗ source
  • Study finds China approved more cancer drugs than US between 2020-2025, but US led in first-in-class and speed
    A new analysis published in Health Affairs compares oncology drug approvals by China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) from 2020 thro…
    raps · 1mo agoRegulatoryNeutral↗ source
  • UK regulator reports rise in drug approvals and steps to regulate AI in healthcare
    The Medicines and Healthcare products Regulatory Agency (MHRA) presented its 2025-2026 annual report to Parliament, highlighting a higher number of new drug approvals compared with the previous yea…
    raps · 1mo agoRegulatoryPositive↗ source
  • Tempus AI to acquire cancer test maker Personalis for $1.5 billion
    Tempus AI announced it will buy Personalis, a Fremont-based company that offers a molecular residual disease test for cancer, in a deal valued at $1.5 billion. The acquisition is expected to expan…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Latigo Biotherapeutics Announces Plans for Nasdaq IPO to Fund Non-Opioid Pain Drug Development
    Latigo Biotherapeutics, a Westlake BioPartners spin‑out founded in 2018, said it will seek a Nasdaq listing under the ticker LTGO. The company develops non‑opioid analgesics that block sodium ion…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Bristol Myers teams with Nvidia to launch large AI data center as Samsung Biologics bids $1.8 bn for Swiss peptide maker
    Bristol Myers Squibb announced expansion of its partnership with Nvidia, deploying two AI systems to create a powerful AI factory for life‑science research, aiming to tackle larger problems without…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Australia's TGA opens consultation to revamp rules for digital mental health tools
    The Therapeutic Goods Administration (TGA) has launched a public consultation aimed at updating the regulatory framework that governs digital mental health tools in Australia. The move seeks to cla…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Zen Principle Moringa Capsules Recalled Over Possible Salmonella Contamination
    Relay Peak Research LLC, operating as Zen Principle Naturals, announced a voluntary recall of its Zen Principle brand Moringa Leaf Powder Capsules. The recall was triggered by a potential contamin…
    fda recalls · 1mo agoCRLNegative↗ source
  • Yusol International expands recall of Ola-Ola Pounded Yam to include 2-, 4-, 5-, and 10-lb packages over undeclared milk allergen
    Fayus Inc., operating as Yusol International Foods in Sacramento, announced an expanded recall of its Ola-Ola Pounded Yam product line. The recall now covers 2‑lb, 4‑lb, 5‑lb and 10‑lb packages af…
    fda recalls · 1mo agoCRLNegative↗ source
  • Compounders still supply about 20% of US GLP-1 weight-loss market despite FDA crackdown and shortages
    A recent Gallup survey shows that while the number of Americans taking GLP-1 weight‑loss drugs has nearly quadrupled over the past two years, roughly one in five are using cheaper, non‑FDA‑approved…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • GSK drops camlipant cough drug after mixed Phase 3 results
    GSK announced it is halting development of camlipant, an experimental chronic cough medicine it acquired in a $2 billion purchase three years ago. The decision follows two Phase 3 trials that show…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Jasper Therapeutics secures $132 million and merges with Kira Pharmaceuticals to revive pipeline
    Jasper Therapeutics, a cash‑strapped biotech, announced it completed an all‑stock acquisition of privately held immune‑drug developer Kira Pharmaceuticals. The merger is paired with a private stoc…
    BioPharma Dive · 1mo agoDealPositive↗ source