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  • FDA approves new treatments for persistent herpes and schizophrenia; Steris to acquire Xodus Medical for $2.1 billion
    The U.S. Food and Drug Administration has granted approvals for two new drugs, one targeting persistent herpes infections and another for the treatment of schizophrenia. The herpes indication addr…
    raps · 9d agoApprovalPositive↗ source
  • FDA finalizes guidance aligning biosimilar post-approval manufacturing changes with global standards
    The U.S. Food and Drug Administration has issued its final guidance on how biosimilar manufacturers can implement post-approval changes to their production processes. The new recommendations bring…
    raps · 9d agoRegulatoryNeutral↗ source
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  • First Tracks reports positive early-stage results for celiac drug ANB033
    First Tracks Biotherapeutics announced that its experimental celiac disease drug ANB033 showed statistically significant improvement in a six‑week early‑stage trial compared with placebo. The trial…
    BioPharma Dive · 9d agoPositive readoutPositive↗ source
  • Undecimal Bio raises $18 million to expand siRNA platform beyond liver diseases
    Undecimal Bio, founded by Yaniv Erlich and Shaul Ilan, announced a new financing round that brings in $18 million. The capital will support the company’s effort to develop siRNA therapeutics for ta…
    Endpoints · 9d agoDealPositive↗ source
  • Japan's PMDA Issues Guidance to Safeguard Participants in Generic Bioequivalence Trials
    The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has released new guidance aimed at protecting healthy adult volunteers who take part in generic bioequivalence studies. The document…
    raps · 9d agoRegulatoryNeutral↗ source
  • Europe’s share of clinical trials falls 13.5% as Asia’s research footprint expands
    The latest data show a 13.5% drop in the number of clinical trials authorized in the EU and EEA compared with pre-pandemic levels. At the same time, Asian countries have increased their share of g…
    raps · 9d agoNeutral↗ source
  • Merck's diabetic eye-disease drug hits primary goal but faces commercial doubts
    Merck announced results from a pivotal trial of its ophthalmology candidate remigromig, aimed at treating diabetic macular edema. The study achieved its primary endpoint, demonstrating that remigr…
    Endpoints · 9d agoNegative readoutNegative↗ source
  • Bausch + Lomb CEO Brent Saunders abruptly departs after failed multibillion-dollar sale
    Brent Saunders, known as a leading dealmaker and one of the highest-paid executives in biopharma, has left his role as chief executive of Bausch + Lomb. His departure ends a second stint as CEO of…
    Endpoints · 9d agoNegative↗ source
  • Bausch + Lomb appoints board chair Thomas Appio as interim CEO after Brent Saunders departs
    Bausch + Lomb announced that board chair Thomas Appio will serve as interim chief executive, taking over immediately from Brent Saunders, who is leaving the role. Appio, who has held several leade…
    BioPharma Dive · 9d agoNeutral↗ source
  • AstraZeneca attributes Phase 3 failure of bone disease enzyme therapy to trial design flaws
    AstraZeneca disclosed that its Phase 3 study of an enzyme replacement therapy for a rare genetic bone disorder did not meet its primary objectives. The company said the shortfall was largely due t…
    Endpoints · 10d agoNegative readoutNegative↗ source
  • Endpoints Weekly releases 2026 Women in Biopharma list of 20 honorees after reviewing 200 nominations
    Endpoints Weekly announced its annual Women in Biopharma 2026 project, highlighting leading women in the industry. The editorial team examined close to 200 nominations to select a shortlist. The…
    Endpoints · 11d agoPositive↗ source
  • Aspen Neuroscience and Bambusa Therapeutics announce plans to go public amid biotech IPO surge
    Aspen Neuroscience, a cell therapy company backed by Gilead, and Bambusa Therapeutics, an I&I biotech founded by former BioNTech scientists, have each filed paperwork to launch initial public offer…
    Endpoints · 12d agoDealNeutral↗ source
  • FDA review flags limited efficacy of Revolution's pancreatic cancer drug Rasonque, shares drop 6%
    Shares of Revolution Medicines fell about 6% after the Food and Drug Administration released review documents that suggest its pancreatic cancer therapy Rasonque may not work as well in all patient…
    BioPharma Dive · 12d agoRegulatoryNegative↗ source
  • RevMed's Rasonque shows weaker response in common KRAS pancreatic cancer mutation, shares fall over 6%
    New data from Revolution Medicines indicates that its KRAS inhibitor Rasonque had a reduced response rate in patients whose pancreatic tumors carry the most common KRAS mutation. The subgroup resp…
    Endpoints · 12d agoNegative readoutNegative↗ source
  • Biotech Index Retraces Gains as Weak Trial Data and Market Fears Weigh
    BioPharma Dive’s latest data‑visualization piece examines why biotech stocks have slipped recently and highlights the rapid pace of startup acquisitions this year. The XBI index, a barometer for b…
    BioPharma Dive · 12d agoNeutral↗ source
  • AI startup Chai Discovery inks GSK deal to develop biologics using artificial intelligence
    Chai Discovery, an artificial‑intelligence focused biotech, has signed a collaboration agreement with GlaxoSmithKline to create biologic medicines using its AI platform. The partnership will lever…
    Endpoints · 12d agoDealPositive↗ source
  • TRexBio raises $117 million in IPO as Retension secures $45 million Nasdaq debut for hypertension therapy
    TRexBio completed its initial public offering on Thursday, pricing the shares at a level that generated about $116.7 million in gross proceeds. The funding will support the company’s development of…
    Endpoints · 12d agoDealPositive↗ source
  • FDA week: HHS launches vaccine injury study, midterms may reshape oversight committees, and patent thickets threaten generics
    The Department of Health and Human Services announced a new agency‑wide effort to examine and address injuries that may be linked to vaccines. The initiative will coordinate research across FDA and…
    raps · 12d agoRegulatoryNeutral↗ source
  • TRex Bio prices $117M IPO to fund Treg-targeted immune therapies
    TRex Bio announced pricing of its initial public offering at $117 million, selling 8,333,334 shares at $14 each, meeting the low end of its earlier guidance. The company will begin trading on Nasd…
    BioPharma Dive · 12d agoDealPositive↗ source
  • Study finds rising patent thickets may slow generic drug competition
    A recent special communication in JAMA reports that the number of patents linked to FDA‑approved small‑molecule drugs has risen over the past 15 years. The increase is driven largely by non‑primary…
    raps · 12d agoNeutral↗ source
  • City Therapeutics plans $158 million IPO as Iambic eyes $135 million Nasdaq debut
    City Therapeutics, an RNAi startup founded by former Alnylam Pharmaceuticals executives, announced plans for an initial public offering targeting roughly $158 million. The company intends to sell a…
    Endpoints · 12d agoDealNeutral↗ source
  • Curium lists Bexlutry at $63,524 per infusion, roughly 5% cheaper than Novartis' Lutathera
    Curium announced the list price for its radioligand Bexlutry, a generic version of Novartis' Lutathera. The price is set at $63,524 per infusion, which represents about a five percent discount com…
    Endpoints · 12d agoNeutral↗ source
  • Viking Therapeutics commercial chief exits after nine months; Gilead eyes BeOne executive for China growth
    Viking Therapeutics' chief commercial officer Neil Aubuchon left the company after only nine months in the role, according to Peer Review. His brief tenure has sparked speculation about the compan…
    Endpoints · 12d agoNeutral↗ source
  • Acting HHS General Counsel Bob Foster Departs Agency
    The acting general counsel for the U.S. Department of Health and Human Services, Bob Foster, is no longer employed by the agency. Endpoints News attempted to reach him via his government email and…
    Endpoints · 12d agoRegulatoryNeutral↗ source
  • Argenx shares tumble 15% after Phase 3 Sjögren’s study of Vyvgart halted for futility
    Argenx reported that an independent monitoring board recommended stopping its Phase 3 trial of Vyvgart in Sjögren’s disease due to futility, based on an interim analysis. The decision came earlier…
    BioPharma Dive · 13d agoNegative readoutNegative↗ source