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  • 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
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  • 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
  • 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 · 1mo agoNeutral↗ 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
  • 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 · 1mo agoDealNeutral↗ source
  • FDA Grants Emergency Use Authorization for Ivermectin Liquid to Prevent New World Screwworm in Horses
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for an ivermectin oral solution intended for horses, aimed at preventing infestations by New World screwworm. The au…
    fda press · 1mo agoRegulatoryNeutral↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoPositive↗ source
  • Erasca seeks $550M in public offering to fund KRAS drug development
    Erasca announced a public offering targeting $550 million to advance its KRAS-targeted drug program. The biotech said the capital will support ongoing research and potential clinical trials for its…
    Endpoints · 1mo agoDealNeutral↗ source
  • AI drug-discovery startup Chai Discovery raises $400 million in Series C, tripling its valuation
    Chai Discovery, a startup focused on using artificial intelligence for drug discovery, announced a new Series C financing round that brought in $400 million. The capital injection was led by existi…
    Endpoints · 1mo agoDealPositive↗ source