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1,328 stories matching this filter · ← front page

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  • UK regulator reports rise in drug approvals and steps toward AI oversight in healthcare
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) released its 2025-2026 annual report to Parliament. The agency highlighted that it approved more new medicines this year than in t…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Kelun-Biotech reports first-line success of Merck-partnered ADC sacituzumab tirumotecan in China
    Kelun-Biotech announced that its antibody‑drug conjugate sacituzumab tirumotecan, developed in partnership with Merck, achieved its primary efficacy endpoints when used as a first‑line therapy in a…
    Endpoints · 1mo agoPositive readoutNeutral↗ source
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  • Reporter attends AHA Leadership Summit in Denver to gauge hospital executives' priorities
    The author attended the American Hospital Association’s Leadership Summit in downtown Denver earlier this week. While there, the author handed out ice cream recommendations to attendees. The prim…
    Endpoints · 1mo agoNeutral↗ source
  • Celcuity receives FDA approval for Revtorpyk, a breast cancer therapy, but shares drop nearly 20% amid launch delay concerns
    Celcuity announced that the U.S. Food and Drug Administration cleared its breast cancer drug Revtorpyk for use in combination with hormone therapy and Pfizer's Ibrance in patients with ER-positive,…
    BioPharma Dive · 1mo agoApprovalNegative↗ source
  • Merck's sac-TMT shows promise in Chinese Phase 3 lung cancer trial, may replace chemo
    Merck and its Chinese partner Kelun-Biotech reported that the antibody-drug conjugate sac-TMT slowed disease progression better than a standard chemotherapy regimen in a Phase 3 trial conducted in…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • FDA acting chief says two journal articles by former commissioner do not represent agency policy
    Acting FDA Commissioner Kyle Diamantas announced that the agency is reversing its earlier position regarding two medical‑journal articles authored by former commissioner Marty Makary. The FDA now…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Johnson & Johnson to spend up to $750 million restructuring pharma manufacturing and closing plants
    Johnson & Johnson announced it will incur up to $750 million as it reshapes its pharmaceutical manufacturing network. The plan involves exiting certain factories and consolidating production, aimi…
    Endpoints · 1mo agoNeutral↗ source
  • AdvanCell secures $315M Series D to advance lead-based prostate cancer therapy
    AdvanCell announced a $315 million Series D financing round aimed at supporting development of its lead-based prostate cancer agent and expanding U.S. manufacturing capacity for the radioactive tre…
    Endpoints · 1mo agoDealPositive↗ source
  • J&J reports 18,000 new prescriptions for Icotyde in first full quarter
    Johnson & Johnson gave an update on the launch of its plaque-psoriasis drug Icotyde. The company said that in its first full quarter on the market, Icotyde generated about 18,000 new prescriptions…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • J&J shares fall 3% as oncology sales miss forecasts, while AstraZeneca invests $600M in lung cancer drug
    Johnson & Johnson’s stock slipped about 3% on Wednesday even though the company raised its full‑year sales outlook. In its latest quarterly earnings release the firm said revenue in its innovative…
    BioPharma Dive · 1mo agoEarningsNeutral↗ source
  • Nava Therapeutics raises $89 million to advance lipid nanoparticle platform targeting bone marrow, immune cells and kidney
    Nava Therapeutics, a stealth-mode biotech, announced it has secured $89 million in financing, according to a statement to Endpoints News. The capital will support development of a next generation…
    Endpoints · 1mo agoDealPositive↗ source
  • Braveheart Bio seeks Nasdaq listing to finance Phase 3 trial of Hengrui rival cardio drug
    Braveheart Bio announced it has filed for an initial public offering on the Nasdaq exchange. The company says the capital raised will be used to fund a Phase 3 study of its cardiovascular candidate…
    Endpoints · 1mo agoNeutral↗ source
  • Insilico Medicine and Bora Pharma launch AI-driven biologics manufacturing venture to challenge Chinese CDMOs
    Insilico Medicine, an AI drug discovery company, and Bora Pharmaceuticals, a Taiwan-based CDMO, announced the formation of a new joint venture. The new company will develop an AI-driven platform t…
    Endpoints · 1mo agoDealPositive↗ source
  • Senate HELP Committee probes CDC director nominee over potential political pressure on vaccine decisions
    Senate HELP Committee held a confirmation hearing for the Trump administration's CDC director nominee, Erica Schwartz, and pressed her on the possibility of political interference. Lawmakers asked…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Eli Lilly invests in Oura to aid patients using GLP-1 medicines
    Eli Lilly announced an equity investment in Oura, a startup that makes a wearable health‑monitoring ring. The partnership is intended to support patients who are prescribed Lilly's GLP-1 medicines…
    Endpoints · 1mo agoDealPositive↗ source
  • Attovia Therapeutics and Braveheart Bio announce plans for biotech IPOs amid market upswing
    Attovia Therapeutics and Braveheart Bio disclosed on Tuesday that they intend to go public, joining a recent wave of large biotech offerings. Attovia, which was spun out of Alamar Biosciences in 2…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Veradermics reports first positive efficacy data for oral minoxidil in women with pattern hair loss
    Veradermics announced that its oral formulation of minoxidil demonstrated positive efficacy in a mid‑stage trial involving women with pattern hair loss. The results mark the company's first effica…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • I&I startup Attovia files to go public as biotech listings momentum builds
    The tally of biotechs waiting to list in the coming weeks has increased to three, as biologics maker Attovia Therapeutics filed for an initial public offering on Tuesday after the market closed. At…
    Endpoints · 1mo ago↗ source
  • Diamantas backtracks on Makary’s policies issued in journal articles
    The acting commissioner of the US Food and Drug Administration (FDA) has clarified that certain policies disseminated in medical journals by former FDA Commissioner Marty Makary are not official ag…
    raps · 1mo ago↗ source
  • CVS Caremark reaches settlement with FTC over insulin suit
    Terms of the deal announced Tuesday are very similar to those the FTC reached with Express Scripts earlier this year, including requiring the PBM to stop preferring higher cost versions of drugs on…
    BioPharma Dive · 1mo ago↗ source
  • Celcuity wins approval for breast cancer drug Revtorpyk
    A small public biotech won approval for a breast cancer drug that was designed to improve on similar treatments from Novartis and Roche. The FDA on Tuesday cleared Celcuity's Revtorpyk in combinati…
    Endpoints · 1mo ago↗ source
  • What's next for BINSA, the House bill restricting China deals
    After setting the industry ablaze last month, a bipartisan bill aimed at restricting US biotech companies from striking deals with Chinese counterparts is in limbo. The Biotech Investment National ...
    Endpoints · 1mo ago↗ source
  • Post-Hoc Live: What’s making biotech IPOs work again?
    Late last year, I found myself talking a lot about what it would take for biotech’s budding rally to become a full one. We had deals, good pipeline readouts and a rising public stock market ...
    Endpoints · 1mo ago↗ source
  • Judge orders Apple Tree partner to forfeit oversight of venture fund
    The ruling from a Cayman Islands court adds a new wrinkle to an ongoing legal dispute that’s already resulted in a bankruptcy filing — and a bid by general partner Seth Harrison for the firm’s port…
    BioPharma Dive · 1mo ago↗ source
  • Fresh off buyout, Akero execs reunite to advance long-acting psoriasis pill
    Set to go public via a reverse merger, Avere has licensed from a prolific Chinese drugmaker rights to a potential threat to medicines like Skyrizi and Icotyde.
    BioPharma Dive · 1mo ago↗ source