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4,105 stories matching this filter · ← front page

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  • Georgiamune to ship preclinical solid tumor drug to Menarini in deal up to $1.1 billion
    Georgiamune, a small biotech based in Maryland, announced that it will supply its preclinical solid tumor candidate to Menarini, a family‑owned pharmaceutical company in Italy. The agreement is st…
    Endpoints · 2h agoDealNeutral↗ source
  • Roche touts strong Phase 3 track record while trimming pipeline amid peer setbacks
    Roche's chief executive Thomas Schinecker highlighted the company's high success rate in Phase 3 trials, positioning it as a competitive advantage. The comment accompanied an announcement that Roc…
    Endpoints · 3h agoPositive↗ source
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  • Rebranded Rezera plans IPO to fund phase 3 trial of NLRP3 inhibitor ruvonoflast for peripheral artery disease
    Rezera, which rebranded from NodThera last month, announced plans for an initial public offering to raise capital for its lead candidate, ruvonoflast, a brain‑penetrant NLRP3 inhibitor. The compan…
    Fierce Biotech · 8h agoDealPositive↗ source
  • Roche CEO says stance on $1.5B Poseida acquisition unchanged despite dropping one CAR-T program
    Roche bought Poseida in 2024 for $1.5 billion to secure its off-the-shelf CAR-T platform and strengthen its cell-therapy portfolio. During the third-quarter earnings call, the company said it has…
    Fierce Biotech · 9h agoDealNeutral↗ source
  • Healthcare groups and tech firms debate FDA evidence requirements for generative AI medical devices
    Healthcare stakeholders are questioning how much clinical evidence the FDA should demand before clearing generative AI-enabled medical devices. The debate centers on balancing innovation speed with…
    Endpoints · 1h agoRegulatoryNeutral↗ source
  • Redesign Health merges with ARC Global in $2B deal to help hospitals build startups
    Health tech venture firm Redesign Health is merging with ARC Global, the innovation arm of Sheba Medical Center, to help hospitals in different countries develop and sell software. The new company…
    Endpoints · 2h agoDealNeutral↗ source
  • Telehealth platforms prescribe GLP-1 drugs off-label for addiction, raising safety concerns
    Telehealth companies have begun prescribing GLP-1 receptor agonists, originally approved for diabetes and obesity, to patients with alcohol, cocaine, methamphetamine or other substance use disorder…
    STAT · 5h agoNeutral↗ source
  • U.S. health insurance premiums rise 9% as uninsured numbers climb, while telehealth firms explore GLP-1 drugs for addiction
    A new survey shows U.S. health insurance premiums increased by 9%, pushing more working‑age adults without coverage in 2026. The rise in costs coincides with a growth in the number of people lackin…
    STAT · 1h agoNegative↗ source
  • Workers face 9% rise in family health insurance premiums in 2026, KFF survey shows
    A new KFF Employer Health Benefits Survey shows that the average cost workers pay for family health insurance jumped 9% in 2026, reaching $7,471 per year. This increase outpaces the 6% and 7% rises…
    STAT · 5h agoNegative↗ source
  • Family's unnamed inherited disease finally identified, offering hope for future generations
    Miranda Pappas, a research methodologist, describes how an inherited condition affected several generations of her family without ever having a formal name. Doctors repeatedly referred to the illn…
    STAT · 5h agoPositive↗ source
  • Economist admits misreading ACA's cost-control promise and calls for reforms
    Dana P. Goldman, director of the USC Schaeffer Institute, recalls signing a 2009 letter with other economists urging Congress to pass the Affordable Care Act. He supported the bill because it promi…
    STAT · 5h agoNegative↗ source
  • STAT+: Pharmalittle: We’re reading about a U.S. rule on Chinese deals, Belgium refusing Mounjaro coverage, and more
    U.S. is poised to issue a proposed rule that would subject outbound licensing deals with Chinese biotech companies to additional scrutiny
    STAT · 30m ago↗ source
  • STAT+: What to expect from the Moderna-Merck cancer vaccine data reveal
    The Moderna-Merck cancer vaccine data reveal is days away. Here's what to expect.
    STAT · 38m ago↗ source
  • STAT+: FDA has finalized its guidance on apps related to drugs
    In this edition of STAT Health Tech: FDA's guidance on prescription drug use-related software, and telehealth pushing GLP-1s for addiction.
    STAT · 55m ago↗ source
  • Menarini's Stemline picks up Georgiamune preclinical cancer immunotherapy in $1.1B deal
    Georgiamune, an immunology-focused biotech out of Maryland, has licensed a preclinical cancer drug candidate to Stemline Therapeutics, owned by Italy's Menarini Group, for up to $1.1 billion.
    Fierce Biotech · 5h ago↗ source
  • Quest Diagnostics’ test results system breached in yet another medtech cyberattack
    Quest Diagnostics is the latest life sciences company to fall victim to a cyberattack, with the company believing patient records have been compromised.
    Fierce Biotech · 5h ago↗ source
  • GSK and Ionis receive FDA nod for Hibsago, a potential functional cure for chronic hepatitis B
    The U.S. Food and Drug Administration has cleared Hibsago, a collaborative product of GSK and Ionis, as the first therapy of its kind aimed at chronic hepatitis B. The medicine is to be added to s…
    BioPharma Dive · 22h agoApprovalPositive↗ source
  • GSK receives FDA approval for hepatitis B therapy that expands functional cure rates
    GSK announced that the U.S. Food and Drug Administration has granted approval for its hepatitis B drug. The agency said the treatment can achieve functional cures in a larger proportion of patient…
    STAT · 23h agoApprovalPositive↗ source
  • GSK and Ionis receive FDA nod for hepatitis B therapy promising functional cure
    GSK and Ionis announced that the U.S. Food and Drug Administration has approved their hepatitis B drug bepirovirsen, now marketed as Hibsago. The therapy is intended for chronic hepatitis B patien…
    Endpoints · 1d agoApprovalPositive↗ source
  • Roche reports up to 30% shrinkage of chronic MS lesions with fenebrutinib, eyes FDA approval
    Roche has filed for FDA approval of its BTK inhibitor fenebrutinib for both relapsing and primary progressive multiple sclerosis, after the agency accepted the submission. At the MSToronto2026 mee…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Roivant's brepocitinib shows strong Phase 3 results, paving way for uveitis indication
    Roivant subsidiary Priovant Therapeutics announced positive Phase 3 data for its anti‑inflammatory drug brepocitinib in patients with non‑infectious uveitis, an eye disease that can cause blindness…
    BioPharma Dive · 22h agoRegulatoryPositive↗ source
  • German biotech Immatics eyes pivotal Phase 3 readout after promising uveal melanoma cell therapy results
    Immatics, a German biotech founded 26 years ago, is focusing on cancer immunotherapy. Its lead candidate is an experimental cell therapy targeting uveal melanoma. Early Phase 1 data in 16 patients…
    STAT · 1d agoPositive↗ source
  • Hologic acquires Spain’s Reveal Genomics to expand breast cancer genomic testing
    Hologic, a medical‑technology company, announced it will acquire precision‑oncology firm Reveal Genomics, based in Spain. Reveal Genomics develops advanced genomic diagnostic tests, notably the HE…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Rezera files for IPO to fund NLRP3 peripheral artery disease program
    Rezera, which rebranded from NodThera earlier this year, has entered the queue for an initial public offering. The filing, submitted on Wednesday, is intended to raise capital to support the compa…
    Endpoints · 14h agoDealPositive↗ source
  • Treasury to tighten scrutiny of China biotech acquisitions under upcoming rules
    Treasury Secretary Scott Bessent announced on Sept 9 2026 that the Treasury Department will issue new guidance that makes it harder for U.S. pharma companies to complete biotech deals in China. Th…
    Endpoints · 19h agoRegulatoryNegative↗ source