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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 · 2mo 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 · 2mo agoPositive readoutNeutral↗ source
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  • Arrow International issues correction for convenience kits containing recalled saline, lidocaine and bupivacaine
    Arrow International, a Teleflex subsidiary, sent a correction notice to customers about certain convenience kits. The kits contain 10 mL saline ampules, lidocaine and bupivacaine. The FDA classifi…
    fda medwatch · 2mo agoCRLNeutral↗ source
  • Khong Guan recalls glutinous rice balls with black sesame filling over possible undeclared peanuts
    Khong Guan Corporation announced a recall of certain lots of its Glutinous Rice Balls with Black Sesame Filling after discovering they may contain undeclared peanuts. The product, sold in 14.1‑oz…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • 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 · 2mo agoNeutral↗ source
  • Merck-Kelun ADC sac-TMT shows progression-free survival benefit with Keytruda in late-stage NSCLC trial
    Kelun-Biotech announced that its antibody‑drug conjugate sac‑TMT, developed with Merck, achieved positive Phase 3 results when paired with Keytruda in a non‑small cell lung cancer trial. The data…
    BioSpace · 2mo agoPositive readoutPositive↗ source
  • J&J restructures pharma supply chain, offloading sites as part of $55 B U.S. manufacturing push
    Johnson & Johnson announced it is restructuring its pharmaceutical supply chain, offloading certain sites to streamline operations as part of its $55 billion U.S. manufacturing initiative. The cha…
    BioSpace · 2mo agoPositive↗ 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo agoPositive readoutPositive↗ 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 · 2mo 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 · 2mo 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 · 2mo agoDealPositive↗ source
  • FDA issues early alert on Resmed Astral ventilators due to electrical component failure risk
    The FDA’s Center for Devices and Radiological Health has released an early alert warning about a possible high-risk problem with certain Resmed Astral ventilators. A defective electrical component…
    fda medwatch · 2mo agoRegulatoryNegative↗ source
  • FDA acting commissioner says Makary’s journal policies are not official guidance; UK regulator reports rise in drug approvals and AI steps
    The acting commissioner of the U.S. Food and Drug Administration clarified that the policies published in medical journals by former commissioner Marty Makary do not constitute official FDA policy…
    raps · 2mo agoRegulatoryNeutral↗ 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 · 2mo 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 · 2mo agoDealPositive↗ source
  • I&I startup Attovia Therapeutics files for IPO as biotech listing wave gains pace
    Attovia Therapeutics, an I&I startup that develops biologics, filed a registration statement to go public on Tuesday after the market closed. The filing brings the number of biotech companies expe…
    Endpoints · 2mo agoDealNeutral↗ 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 · 2mo agoPositive readoutPositive↗ source
  • Khong Guan expands recall of glutinous rice balls over possible undeclared peanuts
    Khong Guan Corporation announced an expanded recall of its Glutinous Rice Balls with Black Sesame Filling and Black & White Glutinous Rice Balls with Black Sesame Filling after discovering they may…
    fda recalls · 2mo agoCRLNegative↗ source
  • AstraZeneca to acquire worldwide rights to Dizal's lung cancer drug Zegfrovy for $600 million
    AstraZeneca announced it will pay $600 million upfront to Dizal Pharmaceutical for the worldwide development and sales rights to the lung cancer drug Zegfrovy. The agreement gives AstraZeneca full…
    Endpoints · 2mo agoDealNeutral↗ source
  • Celcuity receives FDA approval for Revtorpyk breast cancer therapy
    Celcuity, a small public biotech, announced that the U.S. Food and Drug Administration has cleared its drug Revtorpyk for use in breast cancer patients when combined with fulvestrant. The approval…
    Endpoints · 2mo agoApprovalPositive↗ source
  • Bipartisan Bill to Limit US Biotech Deals with China Remains in Limbo
    A bipartisan bill introduced in the House seeks to bar U.S. biotechnology firms from entering into collaborations or licensing agreements with Chinese companies. The proposal sparked strong reacti…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • Live webcast examines why biotech IPOs are gaining momentum again
    Drew Armstrong, executive editor at Endpoints News, announced a live webcast scheduled for July 15 at 12 p.m. ET. The session will feature Parabilis CEO Mathai Mammen and Kailera CEO Ron Renaut, al…
    Endpoints · 2mo agoPositive↗ source