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19 stories matching this filter · ← front page

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  • Menarini to launch Gan & Lee’s GLP-1 drug bofanglutide across Europe in $771 M partnership
    Italian firm Menarini Group has entered a licensing agreement with Chinese insulin producer Gan & Lee Pharmaceuticals to bring the GLP-1 compound bofanglutide to Europe. The deal includes an upfro…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Beyond GLP-1s: Companies eye new obesity drug mechanisms as efficacy plateaus
    The obesity drug market continues to expand, with GLP-1 therapies growing from about $5.5 billion in 2023 to over $55 billion projected for 2033. These agents are used for weight loss, diabetes and…
    BioSpace · 4d agoNeutral↗ source
73
fda recalls67
fda medwatch59
fda press38
856
Ophthalmology488
Pain463
Endocrinology & Metabolism457
Infectious Disease436
  • 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
  • Enveda’s oral obesity pill shows strong GI safety in Phase 1, paving way for trials in patients off GLP-1 drugs
    Enveda reported that its Phase 1 study of the oral obesity candidate ENV-308 demonstrated an exceptional gastrointestinal safety profile in healthy volunteers. The topline data, released on August…
    BioSpace · 18d 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
  • Enveda reports promising Phase 1 data for oral drug that mimics exercise to preserve muscle during weight loss
    Enveda, a biotech based in Boulder, Colorado, announced Phase 1 results for its oral candidate ENV-308, a chemically engineered version of the metabolite lactate phenylalanine (lac-phe). The metabo…
    STAT · 19d agoPositive readoutPositive↗ 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
  • Eli Lilly climbs to top of Norstella’s Pipeline-to-Patient Productivity Index, beating 24 peers
    Eli Lilly has risen to the top of Norstella’s inaugural Pipeline-to-Patient Productivity Index, a new benchmark that rates large global biopharma firms on research productivity, market access and c…
    Fierce Biotech · 1mo agoPositive↗ source
  • Altimmune’s pemvidutide cuts heavy drinking days in phase 2 AUD trial
    Altimmune announced that its experimental dual GLP-1/glucagon receptor agonist pemvidutide reduced heavy drinking in a phase‑2 study of alcohol use disorder. In the 24‑week Reclaim trial, particip…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Altimmune's pemvidutide cuts heavy drinking days in Phase 2 trial
    Altimmune reported that its experimental GLP-1/GIP injection pemvidutide achieved its primary and key secondary goals in a Phase 2 study of alcohol use disorder. The double-blind trial enrolled 10…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Samsung Biologics proposes $1.8B acquisition of PolyPeptide to enter fast-growing obesity peptide market
    Samsung Biologics, a South Korean contract development and manufacturing organization, announced an offer to acquire Swiss CDMO PolyPeptide for CHF 1.46 billion (about $1.8 billion). PolyPeptide s…
    BioSpace · 1mo agoDealPositive↗ 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
  • FDA CDER appoints veteran GLP-1 reviewer Lisa Yanoff as acting deputy director
    Acting FDA CDER director Michael Davis promoted Lisa Yanoff to the role of acting deputy director of the Center for Drug Evaluation and Research. Yanoff is a long‑time FDA employee with deep exper…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • AstraZeneca’s GLP-1 obesity pill shows 10.5% average weight loss after six months in Phase 2 trial
    AstraZeneca reported data from its Phase 2 study of a GLP-1 based oral obesity treatment. The trial showed participants lost an average of 10.5% of body weight after six months of therapy. The re…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Roche's daily incretin injection shows promise in Phase 2 trial for type 1 diabetes
    Roche reported that its experimental daily incretin injection achieved positive results in a Phase 2 study involving patients with type 1 diabetes. The study, the first mid-stage trial of a GLP-1…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • ADA conference preview spotlights newer GLP-1 drugs, research funding cuts and a protest
    Elizabeth Cooney reports from the American Diabetes Association annual meeting in New Orleans, introducing the first of three STAT "ADA in 30 Seconds" newsletters. She notes the warm weather outsid…
    STAT · 3mo agoNeutral↗ source
  • Weight-loss doctor warns against unproven GLP-1 microdosing for cosmetic use
    Dr. Jody Dushay, a Harvard‑affiliated weight‑loss specialist, says patients are asking about tiny doses of GLP‑1 drugs for cosmetic slimming. She notes there is no scientific definition of “microd…
    STAT · 3mo agoNegative↗ source