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10 stories matching this filter · ← front page

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STAT1155Endpoints871BioPharma Dive339BioSpace293Fierce Biotech275onclive165raps104globenewswire health
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allOncology7275Rare Disease1816Cardiology1639Immunology1443Hematology1290Vaccines1172Pulmonology1080Psychiatry & CNS
  • Eli Lilly's Mounjaro gets FDA approval to cut heart attack, stroke risk in type 2 diabetes
    The U.S. Food and Drug Administration has approved Eli Lilly's Mounjaro for reducing the risk of heart attack, stroke, or cardiovascular death in adults with type 2 diabetes who are at high risk fo…
    BioSpace · 9d agoApprovalPositive↗ source
  • Takeda wins FDA nod for orexin drug oveporexton, first treatment for narcolepsy type 1 and potential broader uses
    Takeda received FDA approval for oveporexton (brand Orzeyful), an orexin receptor agonist, marking the first approved therapy that targets the orexin system for narcolepsy type 1. The drug mimics…
    Fierce Biotech · 16d agoApprovalPositive↗ source
73
fda recalls67
fda medwatch59
fda press38
856
Ophthalmology488
Pain463
Endocrinology & Metabolism457
Infectious Disease436
  • Amylyx reports avexitide cuts severe hypoglycemia by 55% in bariatric surgery patients
    Amylyx Pharmaceuticals announced that its GLP-1 blocker avexitide achieved the primary endpoint in a late‑stage trial, reducing serious to severe hypoglycemic events by 55% compared with placebo in…
    BioPharma Dive · 19d agoPositive readoutPositive↗ source
  • Amylyx to seek FDA approval for avexitide after Phase 3 success in post-bariatric hypoglycemia
    Amylyx announced plans to file a new drug application for avexitide, a GLP-1 receptor antagonist, after a Phase 3 trial showed reduction in serious hypoglycemia in patients who had gastric bypass s…
    BioSpace · 19d agoRegulatoryPositive↗ source
  • Amylyx's avexitide halves hypoglycemia episodes in phase 3 trial for post‑bariatric patients
    Amylyx Pharmaceuticals reported that its GLP‑1 receptor antagonist avexitide significantly reduced dangerous blood‑sugar drops in a phase 3 study. The double‑blind Lucidity trial enrolled 78 indiv…
    Fierce Biotech · 20d agoPositive readoutPositive↗ source
  • Podcast explores father's quest for ultra‑rare disease therapy, telehealth GLP‑1 prescribing probe and fugitive posing as biotech exec
    The latest episode of STAT’s "The Readout Loud" podcast examines three distinct stories that intersect with the biotech world. Hosts Allison DeAngelis and Elaine Chen sit down with colleagues Jason…
    STAT · 1mo agoNeutral↗ source
  • Anthropic expands rare disease collaborations as Novo sues Lilly and Agios halts sickle cell drug
    Anthropic, a biotech firm, announced it is expanding its partnership portfolio focused on rare disease therapeutics, deepening collaborations with several companies to advance pipeline candidates.…
    STAT · 1mo agoDealNeutral↗ source
  • Celcuity’s breast cancer therapy gets FDA approval as new CBER chief outlines biotech priorities
    Celcuity announced that its first breast cancer drug has been approved by the U.S. Food and Drug Administration, marking the company’s initial market entry in oncology. The announcement coincided…
    STAT · 1mo agoApprovalPositive↗ source
  • Mwyngil Therapeutics launches obesity program that avoids GLP-1 pathway
    Mwyngil Therapeutics, a newly formed biotech startup, is pursuing obesity treatments that do not target the GLP-1 receptor, a pathway that has dominated recent weight-loss drug development. CEO Lu…
    STAT · 1mo agoNeutral↗ source
  • STAT+: More signs that GLP-1s may help with peripheral artery disease
    Anthropic will begin developing drugs, BridgeBio pockets a billion, and more biotech news from The Readout
    STAT · 2mo agoRegulatoryNeutral↗ source