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493 stories matching this filter · ← front page

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STAT1156Endpoints875BioPharma Dive339BioSpace298Fierce Biotech277onclive165raps104globenewswire health73
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  • Amgen seeks FDA hearing to keep rare kidney drug Tavneos amid safety concerns
    Amgen has asked the U.S. Food and Drug Administration for a hearing to argue against a proposed withdrawal of its rare‑disease drug Tavneos. The company submitted a data package containing real‑wo…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Roche drops Carmot’s acmopatide after Phase 2 success, shifts focus to enicepatide for weight loss and diabetes
    Roche announced it will stop developing acmopatide, an investigational obesity treatment acquired from Carmot Therapeutics. Acmopatide had met its primary endpoint in a Phase 2 trial in type 1 dia…
    BioSpace · 1mo agoNeutral↗ source
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fda recalls67
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fda press38
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Pain470
Endocrinology & Metabolism466
Infectious Disease439
  • Baxter recalls cefazolin injection after cardboard particles detected
    Baxter International announced a voluntary nationwide recall of lot LD175708 of its cefazolin in dextrose injection, a single‑dose 100 ml infusion bag. The recall was prompted by a report that car…
    fda recalls · 1mo agoCRLNegative↗ source
  • FDA issues early alert on Boston Scientific ENROUTE catheter tip separation risk
    The CDRH has issued an Early Alert warning about a potential high risk issue with Boston Scientific's ENROUTE Transcarotid Neuroprotection System and its Plus version. The problem involves possibl…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Baxter voluntarily recalls Cefazolin in Dextrose injection after cardboard particles found
    Baxter International announced a voluntary nationwide recall of Lot LD175708 of its Cefazolin in Dextrose Injection, a single-dose infusion bag. The recall follows a report that cardboard particle…
    fda recalls · 1mo agoCRLNegative↗ source
  • Eli Lilly to seek FDA approval for retatrutide in early 2027 after Phase 3 trials show over 20% weight loss
    Eli Lilly said its next‑generation obesity drug retatrutide produced substantial weight loss in two late‑stage Phase 3 studies. The data were presented from the TRIUMPH‑2 and TRIUMPH‑3 trials, whic…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Biotech hubs from Abu Dhabi to Brazil compete to become the next emerging economy
    Fierce reporters attended the Biotechnology Innovation Organization conference in San Diego to gauge how biotech hubs worldwide are positioning themselves amid tariff concerns and China’s growing i…
    Fierce Biotech · 1mo agoNeutral↗ source
  • BeOne invests $300 million in New Jersey plant, adding small-molecule capacity and 120 jobs
    BeOne Medicines announced a $300 million investment to expand its manufacturing campus in Hopewell, New Jersey. The expansion will include a three‑story, 145,000‑square‑foot building for small‑mol…
    BioSpace · 1mo agoDealPositive↗ source
  • New AMA billing codes set to increase maternity care costs
    The American Medical Association, acting on a recommendation from the American College of Obstetrics and Gynecology, will end the use of global payment codes for deliveries at the end of this year.…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Arrowhead’s plozasiran cuts triglycerides up to 81% in late-stage trials, shows promise for severe hypertriglyceridemia
    Arrowhead Pharmaceuticals reported positive data from two late-stage studies of its RNA-based drug plozasiran in adults with severe hypertriglyceridemia. The trials used a subcutaneous injection e…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Congo Ebola outbreak kills 999, fastest recorded spread with no approved vaccine
    Official data from Congo’s Ministry of Health shows that 2,473 Ebola cases have been recorded and 999 deaths have occurred, with 737 patients still in isolation. The outbreak, declared on May 15,…
    STAT · 1mo agoNegative↗ source
  • AstraZeneca’s rare disease drug Wainua fails Phase 3, narrowing path to $80 billion sales goal
    AstraZeneca announced that its rare disease therapy Wainua did not meet its primary endpoints in a Phase 3 trial, ending plans to broaden the drug’s label for transthyretin amyloidosis cardiomyopat…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • FDA approves Merck’s oral PCSK9 inhibitor Lipfendra, but cardiologists question its immediate impact
    The FDA has granted approval to enlicitide, marketed by Merck as Lipfendra, marking the first oral PCSK9 inhibitor for lowering blood cholesterol. The drug arrives as new clinical guidelines encou…
    STAT · 1mo agoApprovalNeutral↗ source
  • Congressional panel warns US rare-disease lead is eroding and calls for supportive policies
    A Congressional advisory panel has urged the U.S. government to adopt policies that would help rare disease drug development, including a finalized FDA platform designation and the use of novel tri…
    BioSpace · 1mo agoNegative↗ source
  • Maui wildfire study proposes new rural health model for disaster recovery
    Researchers Alika Maunakea and Ruben Juarez are leading one of the largest investigations into the long‑term health effects of the 2023 Lahaina wildfires. The study follows more than 20 participant…
    STAT · 1mo agoPositive↗ source
  • Study finds Merck’s Ervebo may protect against Bundibugyo Ebola strain, prompting calls for DRC testing
    New data from a human study published in the New England Journal of Medicine suggests Merck's Ervebo vaccine, licensed for the Zaire ebolavirus, may also offer protection against the Bundibugyo spe…
    STAT · 1mo agoPositive readoutPositive↗ 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 · 1mo agoNegative readoutNegative↗ source
  • Agios halts development of sickle cell drug tebapivat after mid-stage trial failure
    Agios announced it will stop developing tebapivat for sickle cell disease after a mid-stage trial did not meet expectations. The drug, a next-generation pyruvate kinase activator related to the ap…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • THC-infused drinks found on New York shelves near schools, often sold without ID and breaching state law
    A variety of cannabis-infused beverages are now stocked in grocery stores, bodegas and delis across New York City. Brands such as Oasis, Cann, Milonga, Cycling Frog, Tempters, Gigli and Mighty Kind…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Type 1 diabetes pipeline making ‘remarkable progress’ toward insulin independence
    After the trailblazing approval of Sanofi’s Tzield for stage 3 type 1 diabetes, several companies, including SAB Biotherapeutics and Eledon Pharmaceuticals, are vying for a spot in the landscape wi…
    BioSpace · 1mo agoApprovalPositive↗ source
  • Tempus AI to buy cancer test maker Personalis for $1.5 billion
    Tempus AI announced it will acquire Personalis, a California-based company that offers a molecular residual disease test for cancer, in a transaction valued at $1.5 billion. The deal, priced at $1…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Tempus AI to acquire cancer test maker Personalis for $1.5 billion
    Tempus AI announced it will buy Personalis, a Fremont-based company that offers a molecular residual disease test for cancer, in a deal valued at $1.5 billion. The acquisition is expected to expan…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • U.S. Military's New Testosterone Screening Raises Health Concerns
    The Department of Defense announced a mandatory testosterone screening program for all service members, prompting discussion among medical experts. A urologist who studies men’s health cautions th…
    STAT · 1mo agoNegative↗ source
  • STAT invites reader letters on primary care value, obesity as disease and broader health-care debates
    STAT’s First Opinion platform encourages readers to submit letters responding to its essays, fostering open, good‑faith discussion about health‑care topics. Recent letters, echoing comments from t…
    STAT · 1mo agoNeutral↗ source
  • FDA approves Lipfendra, first oral PCSK9 inhibitor, to lower LDL cholesterol in adults
    The U.S. Food and Drug Administration has approved Lipfendra (enlicitide), the first oral inhibitor of the PCSK9 protein, for use as an adjunct to diet and exercise in adults with high cholesterol,…
    fda press · 1mo agoApprovalPositive↗ source