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1,148 stories matching this filter · ← front page

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  • Mirador Therapeutics announces partnership to acquire Kira drug, positioning it against Tavneos
    Mirador Therapeutics, a San Diego‑based biotech focused on immune diseases and backed by more than $650 million in venture capital, has disclosed a new element of its development pipeline. The com…
    Endpoints · 1mo agoDealPositive↗ source
  • Alzheimer researcher Betty Tijms urges broader view beyond amyloid and tau
    Betty Tijms, head of science at the Alzheimer Center Amsterdam, says it is time to stop treating Alzheimer’s as a single disease. For more than a century, research has focused on two proteins, amy…
    Endpoints · 1mo agoNeutral↗ source
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  • FDA issues first AI-focused cGMP warning letter, flagging oversight gaps for manufacturers
    The FDA has issued its first warning letter that explicitly addresses the use of artificial intelligence in pharmaceutical manufacturing, targeting Purolea Cosmetics Lab. The letter cites AI‑gener…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Three biotech firms launch IPOs to challenge giants in cardiometabolic and immunology markets
    Braveheart Bio, Attovia Therapeutics and Vogenx filed for initial public offerings this week, adding to a surge of biotech listings in 2026. Braveheart is developing a therapy for hypertrophic car…
    BioSpace · 1mo agoDealNeutral↗ source
  • Podcast explores non-opioid and regenerative approaches to pain relief
    In a recent episode of the Denatured podcast, Lance Alstodt, chairman and CEO of BioRestorative Therapies, and Paul Mieyal, chief business officer of South Rampart Pharma, discuss why pain remains…
    BioSpace · 1mo agoPositive↗ source
  • J&J reports 40% Q2 sales jump for Spravato as psychedelic rivals loom
    Johnson & Johnson said its depression nasal spray Spravato generated $584 million in worldwide revenue in the second quarter, a 40% increase from a year earlier. The company highlighted the drug as…
    BioSpace · 1mo agoEarningsNeutral↗ source
  • Sanofi sues Pfizer and Moderna over alleged infringement of mRNA delivery patents
    Sanofi has filed a lawsuit against Pfizer and Moderna, accusing the two companies of violating its patents covering lipid nanoparticle technology used to deliver mRNA in vaccines. The French drugm…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Eli Lilly to acquire AtaiBeckley for $2.8 billion, signaling deeper bet on psychedelics
    Eli Lilly announced on Thursday that it will acquire psychedelic drug developer AtaiBeckley. The purchase price is set at $2.8 billion paid upfront. The sizable upfront payment highlights Lilly's…
    Endpoints · 1mo agoDealPositive↗ source
  • Stakeholders urge FDA to create drug-repurposing framework that avoids disincentives and stays within authority
    Stakeholders, including patients and healthcare industry groups, told the FDA that repurposing existing drugs offers significant opportunities for new treatments. They warned that any new repurpos…
    raps · 1mo agoRegulatoryNeutral↗ source
  • EMA issues guidance to curb microbial contamination in non-sterile medicines; MHRA reports record drug approvals
    The European Medicines Agency has issued new guidance that outlines technical and organisational measures to reduce the risk of microbial contamination in non-sterile pharmaceutical products. The…
    raps · 1mo agoRegulatoryNeutral↗ source
  • 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
  • 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
  • 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 · 1mo 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 · 1mo 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 · 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
  • 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
  • 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 · 1mo 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 · 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