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2,344 stories matching this filter · ← front page

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  • FDA approves Tregzi, first T‑reg cell therapy to lower chronic GVHD risk in blood‑cancer transplants
    The FDA announced approval of Tregzi, a regulatory T‑cell based immunotherapy designed to improve chronic graft‑versus‑host disease‑free survival for adults with blood cancers undergoing allogeneic…
    fda press · 1mo agoApprovalPositive↗ source
  • Anthropic to launch its own drug-development program using Claude Science AI
    Anthropic, an AI company best known for its Claude models, announced it will begin developing its own drug candidates. Executives said the effort is meant to give the firm hands-on experience appl…
    STAT · 1mo agoPositive↗ source
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  • FDA picks seven firms, including Eli Lilly and Fujifilm, for PreCheck pilot to speed factory inspections
    The FDA announced that it has selected seven companies to join the inaugural PreCheck pilot, a program designed to accelerate the review of manufacturing facilities. The cohort includes large drug…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • AbbVie and Genmab's Epkinly shows positive combo results, moving toward label expansion in DLBCL
    AbbVie and Genmab reported that their bispecific antibody Epkinly achieved a successful outcome when tested together with a commonly used cancer therapy. The data indicate that the combination was…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Uganda reports Marburg cases, adding to regional Ebola crisis
    Uganda has informed the World Health Organization of a Marburg virus outbreak in its western region, confirming at least one case, with some sources indicating two cases. The emergence of Marburg,…
    STAT · 1mo agoNegative↗ 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
  • 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
  • FDA's acting director of cell and gene therapies to leave position
    Vijay Kumar is leaving his role as acting director of CBER's Office of Therapeutic Products and will soon consider options both inside and outside the FDA, he told Endpoints News on Tuesday. Kumar…
    Endpoints · 1mo ago↗ source
  • Sarepta's FDA decision date; Flare gets Anna Protopapas as CEO
    Plus news about Deerfield, InflaRx, Praxis, Nuvectis, Pyxis Oncology, Vistagen, Arcutis Biotherapeutics and Nxera. 🔎 FDA to decide on future of Sarepta exon-skipping drugs by end of February: The…
    Endpoints · 1mo ago↗ source
  • STAT+: All of Us tests a new approach to collect real-world data for research
    The NIH All of Us Research Program has secured thousands of electronic medical records through an innovative use of patient data-sharing networks
    STAT · 1mo ago↗ source
  • STAT+: Investors double down on Bain-backed startup
    FDA's top gene therapy regulator steps down, Trump's plan to lower GLP-1 prices, and more biotech news
    STAT · 1mo ago↗ source
  • STAT+: FDA digital leader hints at coming AI policy updates
    Today's health tech news includes virtual PT for a whole country, what the FDA is considering on AI policy, and more
    STAT · 1mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about Chinese trial sites being probed, RFK Jr. and peptides, and more
    U.S. lawmakers are investigating whether several large drugmakers have been involved ​in clinical trials in China that helped fuel its military capability
    STAT · 1mo ago↗ source
  • Nominations are open for the 2026 Endpoints 11 awards
    There’s never been a higher bar for innovation than right now. Almost any promising molecule quickly has a horde of copycats. Development costs keep rising. Investors are leaning on seemingly safer…
    Endpoints · 1mo ago↗ source
  • How mental health chatbots are trained on therapy sessions
    As people increasingly turn to AI for everyday tasks, companionship and emotional assurance, virtual mental health companies once wary of AI are racing to build out their own chatbots to stay compe…
    Endpoints · 1mo ago↗ source
  • Unicycive gets second CRL for kidney drug as manufacturing woes continue
    Unicycive Therapeutics’ chronic kidney disease drug was rejected by the FDA for a second time over persistent issues at a third-party contract manufacturer. The company’s phosphate binder drug oxyl…
    Endpoints · 1mo ago↗ source
  • Half of states sue over Medicaid work requirements
    FDA peptide panelists, a new study on Covid and flu shots, and more health news from Morning Rounds
    STAT · 1mo ago↗ source
  • Sanofi’s Lumizyme successor passes Phase 3 test in babies with Pompe disease
    Sanofi said its enzyme replacement therapy succeeded in a registrational trial in a severe form of Pompe disease, paving the way for a key label expansion in the US. The French pharma is looking to…
    Endpoints · 1mo ago↗ source
  • Beeline adds $126M to Bain-backed immunology pipeline from Bristol Myers
    Bristol Myers Squibb spinout Beeline Medicines is getting extra love from its existing backers and some of its management team. Bain Capital, the Canada Pension Plan Investment Board, and Bristol M…
    Endpoints · 1mo ago↗ 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