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  • FDA accepts resubmission of Replimune’s RP1 cancer therapy, decision due Aug. 2; Merck KGaA announces $11 B life-sciences spend
    The U.S. Food and Drug Administration has accepted Replimune's resubmitted application for its cancer drug RP1, with a final decision slated for August 2 and an advisory committee meeting planned f…
    BioPharma Dive · 2mo agoRegulatoryNeutral↗ source
  • US biotech faces regulatory push as China licensing deals spark security concerns
    A surge in licensing agreements between Chinese pharmaceutical firms and U.S. biotech companies has been noted, with nearly 100 deals announced since early 2025, prompting worry among investors and…
    BioPharma Dive · 2mo agoRegulatoryNegative↗ source
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fda recalls67
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Infectious Disease439
  • Alkermes CEO targets orexin market after strong narcolepsy pill data
    Alkermes' incoming chief executive outlined a strategy to compete with larger rivals in the emerging orexin drug class. Recent mid-June trial results showed the experimental oral compound alixorex…
    BioPharma Dive · 2mo agoPositive readoutPositive↗ source
  • Precision strategies help de-risk rare disease therapy launches
    Commercializing a rare disease therapy presents a high‑risk, high‑reward scenario for biotech firms. Small patient populations, stringent regulatory requirements, and the need to sustain value beyo…
    Fierce Biotech · 2mo agoNeutral↗ source
  • Endpoints News celebrates ten years of bootstrapped growth and a 50/50 founder partnership
    John Carroll and Arsalan Arif launched Endpoints News a decade ago with no seed funding or investors, describing themselves as completely broke. They built the news service from scratch, relying on…
    Endpoints · 2mo agoPositive↗ source
  • Weekly roundup highlights LGBTQ+ leadership in biopharma and reports of a Novo Nordisk hack
    The latest Endpoints Weekly newsletter was published on June 20, 2026, coinciding with the summer solstice in the northern hemisphere. The issue spotlights the growing visibility of LGBTQ+ leaders…
    Endpoints · 2mo agoNeutral↗ source
  • US launches trade probe into Germany's plan to lower drug prices
    US Department of Commerce announced on June 19, 2026 that it has opened a Section 301 trade investigation targeting Germany’s drug pricing system. The probe follows Germany’s ongoing review of its…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • FDA advisory panel backs Moderna's experimental flu vaccine in adults 50-64, supports accelerated review for 65+
    The FDA's advisory committee voted unanimously to recommend Moderna's mRNA-1010 flu vaccine for adults aged 50 to 64, and also found it beneficial for those 65 and older. The 9-0 vote allows Moder…
    BioPharma Dive · 2mo agoRegulatoryPositive↗ source
  • cAMPfield Therapeutics raises $180 million to develop oral IBD drug prifemilast
    cAMPfield Therapeutics, a California biotech, announced a $180 million Series A financing to advance its oral anti‑inflammatory candidate for inflammatory bowel disease. The investigational drug,…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Novo Nordisk invests $380M to expand manufacturing in Czech Republic and China, while Cellares raises $50M Series D
    Novo Nordisk announced a significant investment to broaden its manufacturing footprint in both China and the Czech Republic. In the Czech Republic, the company is allocating roughly $380 million t…
    Endpoints · 2mo agoDealPositive↗ source
  • Medicare $2,000 out-of-pocket cap boosts use of high-cost drugs, study shows
    A recent study published in JAMA Health Forum examined how the Inflation Reduction Act’s $2,000 annual out-of-pocket limit for Medicare beneficiaries affected drug consumption. The analysis found…
    Endpoints · 2mo agoRegulatoryPositive↗ source
  • FDA advisory panel unanimously backs Moderna’s flu vaccine
    The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend Moderna’s seasonal influenza vaccine. The vote overturns earlier hesitations from previous agen…
    Endpoints · 2mo agoRegulatoryPositive↗ source
  • U.S. Treasury Considers New Screening Rules for Investments in Chinese Biotech
    Treasury Department officials are reviewing possible measures to screen U.S. capital flowing into Chinese biotechnology firms, according to multiple sources familiar with the discussions. The revi…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • Biogen to acquire RayThera in up to $1 billion deal for immunology pipeline
    Biogen announced it will acquire RayThera, a startup founded in 2023, in a deal valued at up to $1 billion. The acquisition gives Biogen access to RayThera’s immunology pipeline, which includes th…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Pfizer CFO Dave Denton to leave; Denali Therapeutics sells $195 million FDA priority review voucher
    Pfizer announced that its chief financial officer Dave Denton will depart on Aug. 15 to take a role outside the pharmaceutical sector. He has been CFO since May 2022. In the interim, finance chief…
    BioPharma Dive · 2mo agoDealNeutral↗ source
  • Pfizer CFO to leave in August as GSK secures approval for urinary-tract infection drug
    Pfizer announced that its chief financial officer, Dave Denton, will step down in August, ending his tenure at the company. GSK reported that it has received regulatory approval for a new treatmen…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • Novocure's electric field therapy fails Phase 3 glioblastoma trial, not extending patient survival
    Novocure announced on Thursday that its electric fields device, used together with standard chemoradiation, did not improve overall survival for patients with glioblastoma in a Phase 3 trial. The…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • Moderna appoints Ester Banque as chief commercial officer and expands Stephen Hoge's responsibilities
    Moderna announced a leadership reshuffle as it readies for upcoming product launches. The company named Ester Banque, who previously led U.S. operations at animal health firm Zoetis, as its new ch…
    Endpoints · 2mo agoNeutral↗ source
  • Eli Lilly's TuneLab AI platform reaches 100 members and integrates Chai's models
    Eli Lilly has built TuneLab, an AI initiative that gives biotech companies free access to a range of artificial‑intelligence tools to support drug discovery and development. The program recently a…
    Endpoints · 2mo agoPositive↗ source
  • F2G and Shionogi report positive Phase 3 results for antifungal candidate olorofim
    F2G and Shionogi announced that their joint antifungal candidate, olorofim, met the primary endpoints in a Phase 3 trial. The data were released Thursday morning and showed the drug performed compa…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • Cardiovascular biotech Kardigan raises $400M in IPO, fourth 2026 $400M+ offering
    Kardigan, a cardiovascular drug startup, priced a $400 million initial public offering on Wednesday, adding to a recent surge in large biotech offerings. The company becomes the fourth biotech in…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Kardigan secures $400 million IPO to fund three clinical-stage cardiovascular candidates
    Kardigan, a New Jersey biotech focused on heart disease, announced it raised $400 million in a Nasdaq initial public offering. The capital will be directed toward advancing three clinical-stage dr…
    Endpoints · 2mo agoDealPositive↗ source
  • Biogen to acquire San Diego biotech RayThera in up to $1 billion deal
    Biogen announced it will acquire RayThera, a San Diego-based biotech, in a transaction valued at up to $1 billion. The agreement specifies that most of the payment will be made through milestone-b…
    Endpoints · 2mo agoDealPositive↗ source
  • RA Capital, Forbion and Sanofi Ventures back Korean eye-drug startup
    RA Capital, Forbion and Sanofi Ventures are reported to be providing financing for a new eye-drug company that is developing its product in Korea. The investment follows a growing pattern where la…
    Endpoints · 2mo agoDealNeutral↗ source
  • Innoviva revives Lyndra's long-acting oral drug platform
    Innoviva, a healthcare asset and royalties holding firm, announced it is bringing back Lyndra's long-acting oral drug delivery platform. The technology, which previously attracted more than $380 mi…
    Endpoints · 2mo agoPositive↗ source