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3,118 stories matching this filter · ← front page

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  • OpenAI’s health chief envisions ChatGPT Health moving patients from answers to actionable steps
    Nate Gross, who leads the health division at OpenAI, spoke at an Endpoints News health briefing about the company’s next steps for its AI health offering. He said the goal is to evolve ChatGPT Hea…
    Endpoints · 7h agoPositive↗ source
  • Employers and consumers poised to reshape healthcare, says Health Tech Day discussion
    Last week the organizers held their second Health Tech Day, featuring an in‑person happy hour in New York and a live virtual stream for remote attendees. The forum focused on how employers and con…
    Endpoints · 6h agoNeutral↗ source
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Nephrology759
Oura to buy AI care startup Counsel Health for $625M
Wearable ringmaker Oura is buying AI primary care startup Counsel Health. Oura is paying $625 million in cash for Counsel, which offers medical AI services as well as virtual visits with doctors. T…
Endpoints · 3h ago↗ source
  • Delix raises $100M to advance at-home psychedelic without hallucinogenic effects
    The series C raise, co-led by Johnson & Johnson’s venture capital arm, will help Delix Therapeutics push its novel psychedelic asset into mid-stage development for major depressive disorder.
    BioSpace · 7h ago↗ source
  • FDA Approves First Factor Xla Inhibitor to Help Prevent Stroke in Certain Adults at High Risk
    FDA today approved Sunharbo (asundexian) 50 mg tablets, the first factor XIa (FXIa) inhibitor for use in combination with antiplatelet therapy to reduce the risk of stroke in adults following a rec…
    fda press · 23h agoApprovalPositive↗ source
  • Lilly's oral GLP-1 Foundayo cuts sleep apnea severity in Phase 3, paving way for second FDA filing
    Lilly said it will submit its oral GLP-1 drug Foundayo for FDA approval in obstructive sleep apnea after a late‑stage trial showed strong efficacy. The Phase 3 ATTAIN-OSA study enrolled about 712…
    BioSpace · 1d agoPositive readoutPositive↗ source
  • Argenx to acquire peptide specialist Unnatural Products in deal worth up to $1.15 billion
    Argenx announced it will purchase Unnatural Products, a peptide discovery biotech, in a transaction that could total up to $1.15 billion. The deal provides $550 million upfront, with additional co…
    BioSpace · 1d agoDealPositive↗ source
  • Novartis' Phase 3 HORIZON trial shows pelacarsen lowers Lp(a) but fails to cut cardiovascular events
    Novartis and Ionis reported that the Phase 3 HORIZON trial of the antisense drug pelacarsen did not improve major adverse cardiovascular events despite markedly lowering lipoprotein(a) levels. The…
    BioSpace · 1d agoNegative readoutNegative↗ source
  • Vir Biotechnology reports 44% undetectable hepatitis delta virus in Phase 3 trial, eyes mid-2027 filing
    Vir Biotechnology announced results from its Phase 3 Eclipse 1 trial of a monthly subcutaneous combination of siRNA therapy elebsiran and monoclonal antibody tobevibart for chronic hepatitis delta.…
    BioSpace · 1d agoPositive readoutPositive↗ source
  • Delix Therapeutics raises $100M Series C to advance non-hallucinatory psychedelic for depression
    Delix Therapeutics announced a $100 million Series C financing round, led by Johnson & Johnson’s venture arm JJDC and joined by investors such as SV Health Investors’ Dementia Discovery Fund, RA Ca…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Windward Bio targets $204M Nasdaq IPO to fund Chinese respiratory drug program
    Windward Bio, a biotech backed by Sanofi, announced plans to go public on Nasdaq with an offering of 10.3 million shares priced between $16 and $18 each. The company expects net proceeds of about $…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • AbbVie and BMS each secure FDA approval, but impact of their neuro‑drug acquisitions remains uncertain
    AbbVie and Bristol Myers Squibb have both received FDA clearance for new Parkinson's treatments, prompting a fresh look at the large neuro‑focused deals they completed last year. AbbVie bought Cere…
    BioSpace · 1d agoDealNeutral↗ source
  • FDA launches Rare Disease Framework to embed patient input early in drug development
    FDA's Center for Biologics Research and Evaluation (CBER) director Karim Mikhail announced a new Rare Disease Framework Initiative aimed at moving patient perspectives from an optional, late‑stage…
    BioSpace · 1d agoRegulatoryPositive↗ source
  • FDA orders label warnings for GLP-1 drugs over rare eye-loss risk
    The U.S. Food and Drug Administration has issued a safety communication that requires all glucagon-like peptide-1 receptor agonist (GLP-1 RA) products to add new warnings to their labeling. The ad…
    fda medwatch · 1d agoRegulatoryNegative↗ source
  • Abiomed issues recall of Automated Impella Controllers due to safety risk
    Abiomed has announced a recall of certain Automated Impella Controllers (AIC) after a review of service records. The FDA classified the recall as the most serious type, warning that continued use…
    fda medwatch · 1d agoCRLNegative↗ source
  • Argenx acquires Unnatural Products for up to $1.15 billion to boost oral peptide platform
    Argenx announced it will buy biotech Unnatural Products, paying $550 million upfront with the total deal value potentially reaching $1.15 billion through development and regulatory milestones. The…
    Fierce Biotech · 1d agoDealNeutral↗ source
  • Third Rock Ventures commits up to $2.16 billion to AI-driven Chinese biotech Funnel Biosciences
    Third Rock Ventures disclosed a partnership with Chinese biotech Funnel Biosciences, committing up to $2.16 billion to support its AI-driven biologics platform. The agreement includes a research c…
    Endpoints · 1d agoDealPositive↗ source
  • FDA mandates label update for all GLP-1 drugs to warn of rare eye disease risk
    The FDA issued a class‑wide labeling requirement for all approved GLP‑1 receptor agonists, adding a warning about non‑arteritic anterior ischemic optic neuropathy (NAION), a rare eye condition that…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • Delix Therapeutics secures $100 million Series C to advance psychedelic pipeline
    Delix Therapeutics announced it has closed a $100 million Series C financing round. The capital will be used to accelerate development of its pipeline of psychedelic and neuroplastogen candidates…
    Endpoints · 1d agoDealPositive↗ source
  • Boehringer Ingelheim to seek approval for obesity injection survodutide after trial shows no added cardiovascular risk
    Boehringer Ingelheim announced it will file for regulatory approval of its investigational GLP-1 based obesity injection, survodutide, in the coming year. The move follows a phase 3 trial that dem…
    Endpoints · 1d agoApprovalNeutral↗ source
  • Compass Pathways to file FDA approval for psilocybin depression therapy within weeks
    Compass Pathways announced it will complete its FDA filing for the psilocybin‑based depression treatment COMP360 in the next two weeks. The company expects the rolling submission to enable a drug…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • J&J/Protagonist’s oral Icotyde shows Phase 3 benefit in psoriatic arthritis but trails AbbVie’s Skyrizi
    A Phase 3 study of Johnson & Johnson and Protagonist Therapeutics’ oral IL‑23 receptor antagonist Icotyde met its primary endpoint, demonstrating improvement in psoriatic arthritis symptoms. In th…
    BioSpace · 1d agoPositive readoutNeutral↗ source
  • Merck's efinopegdutide shows strong MASH resolution in phase 2b trial
    Merck & Co. reported results from a phase 2b trial (MK-6024-013) evaluating efinopegdutide, a GLP-1 and glucagon receptor co-agonist, in patients with metabolic dysfunction-associated steatohepatit…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Eli Lilly to pursue FDA approval for obesity drug in obstructive sleep apnea after positive Phase 3 trial
    Eli Lilly announced that it will seek regulatory approval for its obesity medication as a treatment for obstructive sleep apnea, following a successful Phase 3 study. The trial showed positive res…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • Novo’s IL-6 inhibitor ziltivekimab may target milder cardio-renal patients after Phase 3 miss
    At the American Heart Association meeting, investigators discussed new data on Novo Nordisk’s IL-6 inhibitor ziltivekimab, suggesting it could be studied in patients with less severe cardiovascular…
    BioSpace · 1d agoNegative readoutNeutral↗ source