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1,820 stories matching this filter · ← front page

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  • FDA issues final guidance on developing and labeling prescription drug apps
    The FDA released its final guidance on Tuesday, outlining how drug sponsors should create, distribute, and label software applications that are used together with prescription medicines. The guida…
    raps · 20d agoRegulatoryPositive↗ source
  • Epic introduces prescription marketplace to let doctors and patients compare drug prices
    Epic, a leading electronic health record provider, announced a new prescription marketplace designed to help physicians and patients see price differences across pharmacies. The platform integrate…
    Endpoints · 20d agoPositive↗ source
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  • Astellas teams up with Boston miniprotein startup to explore AI-designed tiny proteins
    Astellas Pharma announced a partnership with a Boston-based startup that specializes in miniproteins, small engineered proteins that can serve as therapeutic agents. The startup leverages artifici…
    Endpoints · 20d agoDealPositive↗ source
  • FDA and UK regulators discuss new frameworks for generative AI oversight
    At the MedTech Conference in Boston, officials from the U.S. Food and Drug Administration and the U.K. Medicines and Healthcare products Regulatory Agency met to talk about how to regulate generati…
    raps · 20d agoRegulatoryNeutral↗ source
  • Merck KGaA to acquire Silence Therapeutics for $1.3 billion, expanding siRNA portfolio
    Merck KGaA, the German science and technology conglomerate, announced an agreement to purchase UK‑based Silence Therapeutics. The deal is valued at about $1.3 billion and gives Merck access to Sil…
    Endpoints · 21d agoDealPositive↗ source
  • Roche signs $400 million upfront deal with China's Hansoh, potential $15 billion partnership
    Roche announced a major collaboration with Chinese biotech Hansoh, committing $400 million upfront. The agreement gives Roche access to Hansoh's drug discovery platform and aims to co-develop cand…
    Endpoints · 21d agoDealPositive↗ source
  • FDA Grants Accelerated Approval for Jemperli Immunotherapy in Locally Advanced Rectal Cancer
    The U.S. Food and Drug Administration has granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab‑gxly). The approval applies to adults with previously untreated stage…
    fda press · 21d agoApprovalPositive↗ source
  • Gilead to launch Phase 3 trial of oral α4β7 inhibitor after promising Phase 2 ulcerative colitis results
    Gilead Sciences announced plans to begin Phase 3 trials next year for its oral α4β7 integrin inhibitor aimed at treating ulcerative colitis. The move follows a Phase 2 dose‑finding study that repo…
    Endpoints · 21d agoPositive readoutPositive↗ source
  • Merck acquires Silence Therapeutics for $1.3B; Hansoh Pharma signs $15B deal with Roche
    German Merck announced the acquisition of Silence Therapeutics in a transaction valued at $1.3 billion. In China, Hansoh Pharma disclosed a partnership with Roche that involves a $15 billion drug…
    raps · 21d agoDealNeutral↗ source
  • Antheia secures $80 million conditional loan from DOD to expand U.S. generic drug manufacturing
    Antheia, a biosynthesis manufacturer, has been awarded a conditional loan of $80 million from the U.S. Department of Defense. The funding is aimed at onshoring the company’s generic drug productio…
    Endpoints · 20d agoDealPositive↗ source
  • EyePoint's Phase 3 trial fails, prompting 53% staff cuts; Lilly signs China drug delivery partnership
    EyePoint, a Watertown, Massachusetts biotech, reported that its experimental therapy did not meet primary endpoints in a Phase 3 study, marking a setback for the company. Following the trial failu…
    Endpoints · 21d agoNegative readoutNegative↗ source
  • Disc Medicine's rare sun-sensitivity drug meets all endpoints in Phase 3 trial
    Disc Medicine announced that its experimental therapy for a rare condition that makes sun exposure painful has completed a Phase 3 study. The trial reported success on every primary and secondary…
    Endpoints · 21d agoPositive readoutPositive↗ source
  • Nouscom secures $135 million Series D to advance lead cancer vaccine into Phase 2
    Clinical-stage biotech Nouscom announced it has closed a $135 million Series D financing round that was oversubscribed. The capital will be used to move its lead cancer vaccine candidate into a Pha…
    Endpoints · 21d agoDealPositive↗ source
  • ESMO 2026 preview spotlights upcoming abstracts from Zai Lab, GSK and Merck
    The European Society for Medical Oncology (ESMO) meeting returns to Madrid in 2026, featuring a slate of abstracts expected from several major biotech and pharmaceutical companies. Among the antic…
    Endpoints · 21d agoNeutral↗ source
  • Sanofi partners with ScionxBio to screen long-acting RNA candidates
    Sanofi has entered into a collaboration with biotech startup ScionxBio to evaluate long-acting RNA candidates. The agreement marks ScionxBio's first partnership since it separated from its former…
    Endpoints · 21d agoDealPositive↗ source
  • Veradermics' oral minoxidil clears late-stage trial endpoints
    Veradermics, a Connecticut‑based biotech, reported that its oral extended‑release formulation of minoxidil, VDPHL01, has completed a late‑stage clinical trial. The drug is a pill version of the wel…
    Endpoints · 21d agoPositive readoutPositive↗ source
  • TriGemX Bio to go public via SPAC to advance migraine drug candidate
    TriGemX Bio, formerly known as Kallyope, said it will become a public company by merging with a special purpose acquisition company. The transaction is aimed at raising capital and accelerating the…
    Endpoints · 21d agoDealNeutral↗ source
  • Massachusetts jury awards former MIT professor David Sabatini $6 million in defamation case
    A Massachusetts jury has ordered a $6 million damages award to David Sabatini, a former professor at MIT and noted biologist. The verdict stems from a defamation lawsuit that Sabatini filed after…
    Endpoints · 20d agoNeutral↗ source
  • Japan’s PMDA releases guidance on evaluating generative AI-enabled medical devices
    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a set of review points aimed at medical devices that incorporate generative artificial intelligence. The guidance outlines th…
    raps · 21d agoRegulatoryNeutral↗ source
  • MedTech firms grow more comfortable with FDA's Quality Management System Regulation amid inspection concerns
    At The MedTech Conference in Boston, a senior industry executive reported that the medtech sector is gradually accepting the new Quality Management System Regulation (QMSR) despite early worries.…
    raps · 21d agoRegulatoryNeutral↗ source
  • AbbVie’s Skyrizi combo beats Skyrizi alone in mid-stage Crohn’s trial
    AbbVie’s Skyrizi-based combination therapy for inflammatory bowel disease worked better than Skyrizi alone in a mid-stage trial in Crohn’s disease, the company said Monday. The new product is coden…
    Endpoints · 21d ago↗ source
  • Endpoints Weekly highlights search for Alzheimer’s ‘statin’, Arrowhead’s tau-lowering injectable and AI Day recap
    Endpoints Weekly released its latest edition, previewing several biotech stories including a quest for a “statin of Alzheimer’s” and new data on Arrowhead’s injectable therapy that reduces tau prot…
    Endpoints · 23d agoNeutral↗ source
  • City Therapeutics raises $200 million in IPO, becoming 26th biotech listing of 2026
    City Therapeutics announced that it has completed a $200 million initial public offering, making it the 26th biotech to go public in 2026. The company, based in Kendall Square, will begin trading…
    Endpoints · 24d agoDealPositive↗ source
  • FDA issues warning letters to drug makers over CGMP lapses and highlights patient rep ties to industry-backed groups
    The FDA has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practice requirements, citing problems with ensuring product sterility and meeting sp…
    raps · 24d agoRegulatoryNegative↗ source
  • Novartis ends mid-stage Fabhalta trial in lupus nephritis citing strategic considerations
    Novartis has terminated its mid-stage trial of Fabhalta (iptacopan) in patients with lupus nephritis, according to a federal clinical trials registry. The company said the decision was driven by s…
    Endpoints · 24d agoCRLNegative↗ source