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  • Hamilton Medical issues updated use instructions for certain breathing circuit sets after serious recall
    Hamilton Medical has sent a letter to customers on May 18, 2026, advising updated use instructions for specific coaxial breathing circuit sets used with its HAMILTON-C1, HAMILTON T-1 and HAMILTON-M…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Ipsen to acquire Swiss biotech Memo Therapeutics in up to €800 million deal for BK virus drug
    Ipsen announced it will purchase Memo Therapeutics, a Swiss biotech, in a transaction valued at up to about €800 million. The agreement provides Memo investors with €200 million upfront and potent…
    BioPharma Dive · 1mo agoDealPositive
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Infectious Disease382
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  • Abivax shares jump 40% after Phase 3 data show no excess cancer risk for ulcerative colitis drug
    Abivax reported new safety data from its Phase 3 trial of obefazimod in ulcerative colitis. The data indicated malignancy rates among trial participants were comparable to background rates observed…
    BioPharma Dive · 1mo agoPositive↗ source
  • BridgeBio secures up to $1 billion in preferred equity as United Therapeutics invests $140 million to acquire Thymmune
    BridgeBio Pharma announced that Sixth Street Partners and HealthCare Royalty will provide up to $1 billion in preferred equity to support its upcoming product launches. The financing is structured…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Upcoming FDA decisions in Q3 2026 could signal agency flexibility
    The piece highlights five FDA actions slated for the third quarter of 2026 that industry participants are tracking. Observers say the outcomes may reveal how flexible the agency will be under its…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Ipsen to buy Kartos Therapeutics for $450M, gaining Phase 3 myelofibrosis drug navtemadlin
    French pharmaceutical company Ipsen announced it will acquire California-based Kartos Therapeutics, paying $450 million upfront. The acquisition gives Ipsen control of navtemadlin, an MDM2 inhibito…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • FDA approves Viridian's Lumvoa, positioning it against Amgen's Tepezza in thyroid eye disease
    The Food and Drug Administration has granted approval for Viridian Therapeutics' drug Lumvoa to treat thyroid eye disease, an autoimmune condition that can cause eye pain, bulging and vision proble…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • Beeline Medicines raises $126.3M, bringing total Series A funding to $426.3M for immune‑drug development
    Beeline Medicines announced an additional $126.3 million in Series A financing, pushing the total raised to $426.3 million. The capital boost was disclosed on Tuesday and follows an earlier spring…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • FDA gene and cell therapy review office loses acting director Vijay Kumar
    Vijay Kumar has announced he will step down from his role as acting director of the Office of Gene and Cell Therapy Reviews within the FDA's Center for Biologics Evaluation and Research. Karim Mik…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Biotech firms raise record funds in 2026, with $2.1 bn round for Isomorphic Labs
    After a few slow years, the biotech financing landscape is showing signs of recovery, though investors remain cautious about where they place capital. A recent PharmaVoice reader poll found that 2…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Biotech sector eyes key clinical trial readouts in H2 2026 across cancer, Alzheimer’s and autoimmune diseases
    The first half of 2026 saw a surge in biotech activity, with record‑high deal flow, several large IPOs and a regulatory environment that appears to be stabilising after a period of uncertainty. An…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Theravance, after clinical setbacks, agrees to $929M buyout
    The acquisition by royalty management company Zymeworks follows a "strategic review" triggered by the failure of a drug for a type of low blood pressure.
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • European regulators give second chance approval to Acadia’s Daybu for Rett syndrome
    European Medicines Agency's CHMP has reversed its earlier negative vote and now recommends marketing authorization for Acadia Pharmaceuticals' drug Daybu (trofinetide) for Rett syndrome. The posit…
    BioPharma Dive · 2mo agoApprovalPositive↗ source
  • 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
  • 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
  • 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
  • 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 to step down; Denali sells a regulatory fast-pass
    A search is underway for a successor to Dave Denton, who took a job outside the pharmaceutical industry. Elsewhere, a new kind of Duchenne gene therapy got venture backing and a GSK deal paid divid…
    BioPharma Dive · 2mo ago↗ source
  • Kardigan extends biotech’s streak of big IPOs with $400M haul
    Including the heart drug developer’s offering, four biotechs in 2026 have raised at least $400 million in IPO proceeds — the most in a single year since 2021, according to BioPharma Dive data.
    BioPharma Dive · 2mo ago↗ source
  • UniQure to file gene therapy for approval, reflecting major shifts at FDA
    The decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts that current FDA leadership may be more flexible in certain cases.
    BioPharma Dive · 2mo ago↗ source
  • Jazz zeroes in on next-gen T cell engagers with AbCellera deal
    The potentially $4 billion collaboration is the latest example of drugmakers working to broaden the use of T cell engagers, which, so far, have had limited success outside of certain blood cancers.
    BioPharma Dive · 2mo ago↗ source
  • A new Westlake-backed biotech takes aim at migraines
    Vedana Therapeutics emerged from stealth Wednesday with $46 million to support its mission of developing “anti-PACAP” therapies, an increasingly popular strategy for migraine prevention.
    BioPharma Dive · 2mo ago↗ source