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1,204 stories matching this filter · ← front page

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  • Trump threatens up to 200% tariffs on generic drugs not manufactured in the United States
    President Donald Trump announced that his administration will consider imposing steep tariffs on generic medicines that are imported rather than produced in the United States. The proposed tariffs…
    Endpoints · 21d agoRegulatoryNegative↗ source
  • FDA selects Dexcom as first participant in TEMPO digital health pilot
    The U.S. Food and Drug Administration announced that Dexcom, Inc. has been chosen as the inaugural manufacturer for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot focused on digit…
    fda press · 21d agoRegulatoryPositive↗ source
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  • NIH joins Trump’s $5B AI Genesis Mission to boost biomedical research
    The U.S. Department of Health and Human Services announced that the National Institutes of Health will take part in the President’s Genesis Mission, a $5 billion AI-driven effort. The initiative a…
    Fierce Biotech · 21d agoRegulatoryPositive↗ source
  • Mentari Therapeutics secures second $200M private placement to fund migraine program and advance reverse merger
    Mentari Therapeutics, a spin‑out focused on migraine treatments, announced it has arranged a second private‑placement financing of $200 million. The new capital will be used to advance its migrain…
    Endpoints · 21d agoDealPositive↗ source
  • Eli Lilly to spend $2.8 billion on AtaiBeckley acquisition as it ramps up Alzheimer’s prevention push
    Eli Lilly is signaling a renewed focus on neuroscience, emphasizing its ambition to tackle brain disorders. The company announced it will pay $2.8 billion upfront to acquire AtaiBeckley, a move in…
    Endpoints · 21d agoDealPositive↗ source
  • Crystalys Therapeutics raises $130M to launch gout drug in US and Europe
    San Diego‑based Crystalys Therapeutics announced a new $130 million Series B financing round. The capital will be used to advance its gout treatment, which already holds regulatory approval in Japa…
    Endpoints · 21d agoDealPositive↗ source
  • Summit Therapeutics shares two-year survival data for its experimental cancer drug ivonescimab in Western patients
    Summit Therapeutics presented new two-year overall survival results for its experimental antibody ivonescimab in Western participants of its global Phase 3 trial. The data were released alongside…
    Endpoints · 21d agoNeutral↗ source
  • Celldex halts development of mast cell antibody after Phase 2 failure in prurigo nodularis
    Celldex announced it will discontinue the clinical program for its mast cell‑targeting monoclonal antibody aimed at treating prurigo nodularis, a chronic itchy‑skin condition. The decision follows…
    Endpoints · 21d agoNegative readoutNegative↗ source
  • Biotech deal activity picks up in Q2 2026, signaling recovery after summer slump
    The biotech sector experienced a sharp decline in confidence last summer, leading to a slowdown in financing and partnership activity. New data show that in the second quarter of 2026, dealmaking…
    Endpoints · 21d agoDealPositive↗ source
  • House passes FDA Modernization Act 3.0 to push update of animal testing regulations
    The U.S. House approved the FDA Modernization Act 3.0, a bill aimed at modernizing preclinical testing rules. The legislation requires the FDA to revise regulations that still reference animal tes…
    Fierce Biotech · 21d agoRegulatoryPositive↗ source
  • Vertex pays second-highest M&A premium as sole bidder for Crinetics
    Vertex Pharmaceuticals emerged as the only bidder for Crinetics Pharmaceuticals, aiming to acquire the company. The bid involved a premium that ranks as the second-highest in the biopharma sector…
    Endpoints · 21d agoDealNeutral↗ source
  • Royalty Pharma pays $125M upfront for royalty stake in AstraZeneca’s ATTR drug cliramitug
    Royalty Pharma has entered a deal to acquire a royalty interest in a transthyretin amyloidosis drug being developed by AstraZeneca. The agreement involves an upfront payment of $125 million to Neu…
    Fierce Biotech · 21d agoDealPositive↗ source
  • FDA sends warning letters to Sanofi and Viatris over misleading product claims
    The FDA’s Office of Prescription Drug Promotion issued untitled warning letters to Sanofi and Viatris after reviewing promotional materials that the agency deemed misleading. The letters cite spec…
    raps · 21d agoRegulatoryNegative↗ source
  • Arrowhead's gene-silencing therapy shows strong results in two late-stage triglyceride trials
    Arrowhead Pharmaceuticals reported positive data from its lipid-lowering gene-silencing candidate Redemplo in two late-stage studies. The results suggest the therapy effectively reduces triglyceri…
    Endpoints · 21d agoPositive readoutPositive↗ source
  • Celldex halts skin disease program after barzolvolimab fails phase 2 trial
    Celldex Therapeutics announced it is discontinuing development of its anti‑KIT antibody barzolvolimab for chronic skin disorders after the drug failed to meet its primary endpoint in a phase 2 stud…
    Fierce Biotech · 21d agoNegative readoutNegative↗ source
  • FDA moves to reverse policies of former commissioner Marty Makary
    The Trump administration is actively rolling back decisions made under former FDA commissioner Marty Makary. As the White House weighs a new nominee for the agency, officials have begun revisiting…
    Endpoints · 21d agoRegulatoryNegative↗ source
  • Former FDA oncology chief calls for agency restructuring after recent staff cuts
    Richard Pazdur, who led the FDA’s Oncology Center of Excellence for more than twenty years, said the agency now faces a "golden opportunity" to restructure its operations. He made the comments aft…
    Endpoints · 21d agoRegulatoryNeutral↗ source
  • MDCG: Only manufacturers should assign UDI-DIs
    The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better…
    raps · 21d agoNeutral↗ source
  • FDA revokes Orange B color additive and proposes to drop Citrus Red No. 2 from food approvals
    The U.S. Food and Drug Administration issued a final order that revokes the authorized use of Orange B as a food color additive. The agency also proposed revoking Citrus Red No. 2, a pigment autho…
    fda press · 21d agoRegulatoryNeutral↗ source
  • Gilead and Merck to unveil detailed Phase 3 results of once‑weekly oral HIV regimen at AIDS 2026; Dimension Capital launches $800M fund
    Gilead Sciences and Merck announced that they will present detailed results from their Phase 3 trials of a once‑weekly oral HIV treatment regimen at the upcoming AIDS 2026 conference. The data wil…
    Endpoints · 22d agoNeutral↗ source
  • Agios halts sickle cell drug program after disappointing phase 2 results
    Agios announced it is stopping development of its next‑generation pyruvate kinase activator, tebapivat, for sickle cell disease after a phase 2 trial failed to meet expectations. The study enrolle…
    Fierce Biotech · 22d agoNegative readoutNegative↗ source
  • FDA issues warning letter to Alembic Pharmaceuticals over missing patient consent in clinical study
    The U.S. Food and Drug Administration sent a warning letter to Indian generic manufacturer Alembic Pharmaceuticals after it was found to have failed to obtain informed consent from participants in…
    Endpoints · 22d agoRegulatoryNegative↗ source
  • Biotech firms rally to defend FDA's mifepristone approval in Louisiana lawsuit
    Biotech companies, executives and investors filed an amicus brief supporting the FDA in the Louisiana case that seeks to limit access to the abortion pill mifepristone. The brief is signed by 61 e…
    Fierce Biotech · 22d agoRegulatoryPositive↗ source
  • FDA to appoint permanent heads of CBER and CDER alongside new commissioner
    The FDA is preparing to announce a series of senior leadership changes concurrent with the appointment of a new commissioner. Among the planned announcements are permanent appointments for the hea…
    Endpoints · 22d agoRegulatoryNeutral↗ source
  • Agios halts development of next‑generation sickle‑cell drug tebapivat after disappointing mid‑stage trial
    Agios Therapeutics announced it will discontinue development of tebapivat, a next‑generation therapy for sickle cell disease, after the drug failed to demonstrate sufficient efficacy in a Phase 2 t…
    Endpoints · 22d agoNegative readoutNegative↗ source