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912 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 · 29d 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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  • 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
  • B. Braun pulls spinal anesthesia kits after recall of bupivacaine in dextrose injection
    B. Braun Medical, Inc. has issued a recall of several spinal anesthesia convenience kits that contain Huons bupivacaine hydrochloride in dextrose injection. The recall follows a request from Huons…
    fda medwatch · 1mo agoCRLNegative↗ 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
  • 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 · 1mo agoCRLNeutral↗ 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
  • FDA acting chief walks back Makary's practice of policymaking through journals
    The FDA is continuing to rewind actions by former Commissioner Marty Makary, saying that two medical journal articles published over the last year did not constitute agency policy. The about-face f…
    Endpoints · 1mo ago↗ source
  • Senate committee questions CDC pick on political interference over vaccines
    Lawmakers in the Senate pressed the Trump administration’s nominee for CDC director on whether she will cave to political pressure during a confirmation hearing on Wednesday. The CDC has been witho…
    Endpoints · 1mo ago↗ source
  • J&J restructures pharma manufacturing footprint at cost of up to $750M
    Johnson & Johnson is anticipating as much as $750 million in costs to restructure its pharmaceutical supply chain and exit factories, moves that are coming as it pushes ahead with its $55 billion p…
    Endpoints · 1mo ago↗ source
  • Eli Lilly invests in Oura to support patients on GLP-1 drugs
    Eli Lilly on Wednesday made an equity investment in wearable ring startup Oura as the drugmaker looks for ways to support patients taking its GLP-1 medications. An Oura spokesperson declined to sha…
    Endpoints · 1mo ago↗ source
  • Radiopharma maker AdvanCell hauls in $315M for Pluvicto challenger
    AdvanCell raised a $315 million Series D to study a lead-based prostate cancer agent and shore up its US manufacturing of the radioactive treatment. The round marks one of the largest yet for a rad…
    Endpoints · 1mo ago↗ source
  • J&J touts Icotyde prescriptions, but not sales, in first full quarter
    Johnson & Johnson teased some details on Wednesday morning about how the launch of its expected blockbuster Icotyde performed in the second quarter. Without disclosing how much revenue the plaque p…
    Endpoints · 1mo ago↗ source
  • Nava Therapeutics emerges with $89M for lipid nanoparticles
    Nava Therapeutics, a secretive startup that’s been working on a new generation of lipid nanoparticles that target the bone marrow, immune cells and the kidney, has raised $89 million, the company t…
    Endpoints · 1mo ago↗ source
  • Braveheart files for IPO to fund Phase 3 of Hengrui's Cytokinetics rival
    Biotechs are sprinting to the IPO queue. In the industry's fourth IPO filing in two weeks, Braveheart Bio is seeking a Nasdaq listing to fuel Phase 3 testing of a cardio drug that could potentially…
    Endpoints · 1mo ago↗ source
  • Insilico, Bora Pharma reveal plans for AI-driven manufacturing company
    Insilico Medicine and Taiwan-based CDMO Bora Pharmaceuticals are launching a new company with an AI-driven biologics manufacturing platform in a bid to compete with service providers headquartered…
    Endpoints · 1mo ago↗ source
  • Veradermics declares first efficacy win in women for hair loss drug
    Veradermics is for the first time reporting positive efficacy of its oral formulation of minoxidil in female pattern hair loss, which broadens the market potential of its flagship asset. In a mid-s…
    Endpoints · 1mo ago↗ 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
  • Early Alert: Ventilator Issue from Resmed
    Failure of an electrical component in certain Astral ventilators may cause an interruption or failure in therapy which may result in serious injury or death
    fda medwatch · 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
  • 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