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  • Sarepta receives FDA decision deadline for exon-skipping therapies, appoints Anna Protopapas as Flare CEO
    The U.S. Food and Drug Administration has set a deadline for a decision on Sarepta Therapeutics' exon‑skipping drug program, with the agency expected to rule by the end of February. The timing is…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Investors increase stakes in Bain-backed biotech startup as FDA gene‑therapy chief departs
    Investors are putting more money into a biotech startup backed by private‑equity firm Bain Capital, according to the STAT+ newsletter. Vijay Kumar is leaving his role as acting director of the FDA…
    STAT · 1mo agoDealNeutral↗ source
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Infectious Disease367
  • US lawmakers probe Chinese clinical trial sites for potential military links involving major drugmakers
    A bipartisan group of U.S. lawmakers has launched a national‑security investigation into whether several large pharmaceutical companies participated in clinical trials at Chinese sites that may hav…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Unicycive Therapeutics receives second FDA complete response letter for kidney drug amid manufacturing problems
    Unicycive Therapeutics' chronic kidney disease drug, a phosphate binder called oxylanthanum carbonate (OLC), has been rejected by the U.S. Food and Drug Administration for a second time. The FDA c…
    Endpoints · 1mo agoCRLNegative↗ source
  • Beeline Medicines secures $126M from Bain Capital, CPPIB and Bristol Myers to expand immunology pipeline
    Beeline Medicines, a spinout from Bristol Myers Squibb, announced it has received an additional $126 million in financing. The new capital comes from existing investors Bain Capital and the Canada…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA reviewers recommend against adding seven peptides to bulk drug list for compounding
    FDA reviewers have advised that seven widely used peptides should not be added to the FDA's bulk drug substance list for compounding. Their recommendation comes before an upcoming advisory committe…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Anthropic launches Claude Science AI platform tailored for pharmaceutical research
    Anthropic announced the availability of Claude Science, an AI application built on its large language model and aimed at scientific laboratories and pharmaceutical research. The tool is intended t…
    STAT · 1mo agoPositive↗ source
  • Abivax reports ulcerative colitis trial cancer rates align with expectations
    Abivax released new data from its Phase 3 trial of an ulcerative colitis candidate. The data show that the number of cancer cases observed was within the range normally expected for ulcerative col…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Anthropic launches Claude Science, AI platform aimed at bioscience and drug discovery
    Anthropic, known for its Claude Code AI coding assistant, announced a new product called Claude Science aimed at the life‑science sector. The platform is designed to help biopharma researchers wit…
    Endpoints · 1mo agoPositive↗ source
  • FDA digital chief signals upcoming AI regulatory guidance
    STAT+ health-tech newsletter reported that the FDA’s digital leader offered a preview of forthcoming guidance on artificial intelligence. The briefing, delivered by Rick Abramson, highlighted the a…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Half of U.S. states file lawsuits challenging Medicaid work-requirement rules
    A coalition of states has filed legal challenges against recent Medicaid work‑requirement policies, arguing that the rules threaten access to health coverage for low‑income residents. The lawsuits…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Health tech executives grow confident in AI, survey shows sharp shift in attitudes
    A yearly survey conducted by Venrock partners Bob Kocher, Bryan Roberts and Siobhan Nolan Mangini reveals that confidence in using artificial intelligence within healthcare has risen sharply over t…
    Endpoints · 1mo agoPositive↗ source
  • Rep. Tom Kean Jr. Discloses Depression Diagnosis After Four-Month Congressional Absence
    Rep. Tom Kean Jr., a Republican congressman from New Jersey, announced on the House floor that he has been receiving treatment for depression, which explains his unexplained four-month absence from…
    STAT · 1mo agoNeutral↗ source
  • Virtual mental-health firms accelerate AI chatbot development using therapy session data
    People are turning to artificial intelligence for daily tasks, companionship and emotional support, prompting virtual mental‑health providers to explore AI solutions. Companies that were previousl…
    Endpoints · 1mo agoNeutral↗ source
  • FDA acting director of cell and gene therapies Vijay Kumar to depart his post
    Vijay Kumar, who has been serving as the acting director of the Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products, announced he will leave his position. In an inte…
    Endpoints · 1mo agoNeutral↗ source
  • Nominations Open for 2026 Endpoints 11 Biotech Awards
    Nominations for the 2026 Endpoints 11 awards are now being accepted, with submissions due by July 15. The awards target private biotech startups that have differentiated science, strong leadership…
    Endpoints · 1mo agoNeutral↗ source
  • BeOne’s Brukinsa succeeds in frontline mantle cell lymphoma study
    BeOne Medicines said its BTK inhibitor Brukinsa cut the risk of disease progression or death by 43% compared to chemoimmunotherapy when used as a first option for mantle cell lymphoma patients. The…
    Endpoints · 1mo ago↗ source
  • House China panel probes Bristol Myers, Pfizer on use of trial sites
    A congressional committee has opened an inquiry into Bristol Myers Squibb and Pfizer's use of clinical trial sites in China, including facilities that the committee's chairman said are affiliated w…
    Endpoints · 1mo ago↗ source
  • STAT+: Even with MAHA, Trump administration has gone soft on alcohol
    A STAT investigation has found that the Trump administration has downplayed alcohol’s risks and actively derailed efforts to understand and prevent drinking-related harms.
    STAT · 1mo ago↗ source
  • Opinion: Florida is the first state to require EKGs for high school athletes. It’s a mistake
    “There are better ways for schools to protect student athletes,” writes Katherine Hofmann.
    STAT · 1mo ago↗ source
  • STAT+: The loophole in Trump’s obesity drug deal with Eli Lilly and Novo Nordisk
    The Trump administration's grand bargain with drugmakers isn't working out as planned.
    STAT · 1mo ago↗ source
  • Opinion: Short-sighted new student loan caps elevate chiropractic care over critical health care professions
    “This administrative logic is hopelessly out of touch with the empirical reality of American health care,” writes David S. Shapiro.
    STAT · 1mo ago↗ source
  • STAT+: Abivax seeks to ease safety concerns with new data, boosting shares
    Safety concerns tied to Abivax's experimental bowel disease drug tanked company shares just weeks ago. But a new analysis sent them climbing.
    STAT · 1mo ago↗ source
  • STAT+: FDA’s top gene therapy regulator is leaving his role
    The departure of Vijay Kumar follows a broader leadership shakeup at the FDA.
    STAT · 1mo ago↗ source
  • NEJM retracts pivotal data for Amgen's Tavneos
    Pivotal data for Amgen’s Tavneos have been retracted from the New England Journal of Medicine, creating another obstacle for the beleaguered autoimmune drug. Two academic authors requested the retr…
    Endpoints · 1mo ago↗ source