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2,461 stories matching this filter · ← front page

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  • AstraZeneca’s Tagrisso plus Orpathys improves survival in MET-mutated lung cancer
    A new combination therapy using AstraZeneca’s Tagrisso together with Hutchmed’s Orpathys has shown a survival benefit for patients with a specific form of non‑small cell lung cancer. The study focu…
    BioPharma Dive · 2d agoPositive readoutPositive↗ source
  • Leo Pharma to acquire experimental rare-skin disease drug dersimelagon in up to $435 million deal
    Leo Pharma announced it will acquire the rights to dersimelagon, an experimental oral therapy currently under FDA review, in a transaction that could total up to $435 million in upfront and near‑te…
    BioPharma Dive · 2d agoDealNeutral↗ source
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fda recalls44
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Psychiatry & CNS712
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Endocrinology & Metabolism382
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Infectious Disease356
  • Eyepoint’s Phase 3 trial for age‑related blindness treatment fails primary endpoint, jeopardizing approval plans
    Eyepoint announced that its Phase 3 trial of the experimental drug Duravyu for a common cause of age‑related blindness did not meet its primary endpoint. Patients receiving the investigational ther…
    STAT · 2d agoNegative readoutNegative↗ source
  • 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 · 2d agoPositive readoutPositive↗ source
  • Amylyx avexitide cuts serious low blood sugar events by 55% in Phase 3 trial for post bariatric hypoglycemia
    Amylyx Pharmaceuticals reported that its experimental drug avexitide significantly reduced the frequency of serious low blood sugar episodes in a Phase 3 study of patients with post‑bariatric hypog…
    STAT · 2d agoPositive readoutPositive↗ source
  • Academic groups sue DHS over new four-year visa limit for foreign graduate students and postdocs
    Groups representing universities and educators filed a lawsuit in U.S. District Court in Massachusetts against the Department of Homeland Security. The suit challenges a new DHS rule that would re…
    STAT · 2d agoRegulatoryNegative↗ source
  • Amylyx reports positive pivotal trial results for drug targeting post-bariatric hypoglycemia
    Amylyx announced that its experimental therapy achieved statistically significant improvement in patients who experience severe hypoglycemia after bariatric surgery. The company said the pivotal t…
    STAT · 2d agoPositive readoutPositive↗ source
  • CSL Vifor warns Tavneos exit from Europe will cut revenue by about 25%
    CSL Vifor’s parent company CSL Limited said the withdrawal of the drug Tavneos from the European market creates a significant headwind for sales. The company expects its revenue to fall by roughly…
    Endpoints · 2d agoRegulatoryNegative↗ source
  • BioMarin to buy Alesta Therapeutics for $275M, adding rare bone disease drug to pipeline
    BioMarin announced Tuesday that it will acquire privately held Alesta Therapeutics, paying $275 million upfront with potential additional payments tied to milestones. The deal, expected to close b…
    BioPharma Dive · 2d agoDealPositive↗ source
  • Municipalities and States Grapple with Rising Health-Insurance Costs and Upcoming Medicaid Drug Pricing Deadline
    Municipalities across the country are reporting that the cost of providing health insurance to their employees is becoming increasingly unsustainable, putting pressure on local budgets. States are…
    STAT · 2d agoRegulatoryNegative↗ source
  • Third patient dies in Chinese trial of RiboX Therapeutics' experimental genetic therapy
    A patient with an autoimmune disease died after receiving an experimental genetic medicine from RiboX Therapeutics, a Shanghai‑based biotech startup. The death marks the third fatality reported in…
    Endpoints · 2d agoNegative↗ source
  • LEO Pharma spends $435 million to acquire rare-disease skin drug dersimelagon
    LEO Pharma announced it will pay $435 million to buy the rights to dersimelagon, an oral MC1R agonist originally developed by Tanabe Pharma. The drug has completed Phase 3 trials for two rare phot…
    BioSpace · 2d agoDealPositive↗ source
  • GenBio AI launches AIDO Cell, a virtual model that simulates whole-cell behavior
    GenBio AI, a Palo Alto startup, unveiled AIDO Cell, a virtual cell platform that lets researchers view a cell’s interior like a map. The system visualizes proteins, RNA and DNA and can simulate gen…
    STAT · 2d agoPositive↗ source
  • Biotech funding rebound set to boost CDMO demand by early 2027
    Analysts note that demand for pharma services has historically lagged behind biotech funding, but a recent surge in venture capital is expected to drive activity for contract development and manufa…
    BioSpace · 2d agoPositive↗ source
  • Regeneron halts Phase 1/2 uveitis antibody trial after safety concerns
    Regeneron announced termination of a Phase 1/2 study of its investigational anti-inflammatory antibody REGN7041, which was being evaluated for non-infectious uveitis. The company said the decision…
    BioSpace · 2d agoNegative↗ source
  • Regeneron halts Phase 1/2 uveitis antibody trial over unfavorable risk-benefit profile
    Regeneron has stopped a Phase 1/2 study of its anti‑inflammatory antibody REGN7041 in non‑infectious uveitis, citing an unfavorable benefit‑risk assessment. The antibody targets CD3 on immune cell…
    BioSpace · 2d agoNegative readoutNegative↗ source
  • Amylyx reports Phase 3 success for avexitide in post-bariatric hypoglycemia
    Amylyx announced a late-stage success for avexitide, a GLP-1 receptor antagonist, in a Phase 3 trial targeting post-bariatric hypoglycemia. The trial results showed the drug achieved its primary e…
    Endpoints · 2d 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 · 2d 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 · 2d agoPositive readoutPositive↗ source
  • Study shows antibiotic overuse is concentrated in high-income nations, while low-income countries struggle with shortages
    Peter Beyer, deputy executive director of the Global Antibiotic Research & Development Partnership, writes an opinion piece highlighting a shift in how antimicrobial resistance is framed across the…
    STAT · 2d agoNeutral↗ source
  • Leo Pharma to license Tanabe’s oral drug for rare light-sensitive skin disease, paying up to $435 million
    Leo Pharma announced a licensing agreement with Japan's Tanabe Pharma for an oral treatment targeting two genetic skin disorders that cause pain when exposed to sunlight. Under the deal, Leo Pharm…
    Endpoints · 2d agoDealNeutral↗ source
  • FDA issues draft guidance for generative AI medical devices as industry calls for German drug pricing reform
    The U.S. Food and Drug Administration has published a draft guidance document that outlines the agency's expectations for medical devices that incorporate generative artificial intelligence. The dr…
    raps · 2d agoRegulatoryNeutral↗ source
  • Former NIAID adviser David Morens pleads guilty to concealing records and defrauding government
    David Morens, a former top National Institute of Allergy and Infectious Diseases official and longtime senior adviser to former NIAID leader Anthony Fauci, entered a guilty plea on Tuesday on charg…
    STAT · 2d agoRegulatoryNegative↗ source
  • BioMarin signs new deal for early-stage bone disease asset
    BioMarin recently halted development of a rare disease drug that it had acquired in a $270 million transaction. Within a week, the company announced another deal to acquire an early‑stage asset aim…
    Endpoints · 2d agoDealNeutral↗ source
  • Sandoz inks $322M Henlius deal for rights to as many as 10 biosimilars
    The initial batch of biosimilars includes copies of Amgen, Eli Lilly and GSK drugs that collectively generate billions of dollars in annual revenues.
    BioSpace · 2d agoDealNeutral↗ source