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1,413 stories matching this filter · ← front page

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  • 92Bio revives experimental T cell engager previously handed to Amgen
    92Bio, a small California biotech, announced it is bringing back an experimental T‑cell engager it originally created before transferring the program to Amgen. The company said the candidate will…
    Endpoints · 1mo agoNeutral↗ source
  • Sanofi’s Pompe disease enzyme therapy clears Phase 3 in infants, opening US label expansion
    Sanofi announced that its next‑generation enzyme replacement therapy for Pompe disease met its primary endpoints in a registrational Phase 3 trial involving infants with the severe infantile‑onset…
    Endpoints · 1mo agoPositive readoutPositive↗ source
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  • BeOne’s Brukinsa cuts risk of progression or death by 43% in frontline mantle cell lymphoma Phase 3 trial
    BeOne Medicines reported that its BTK inhibitor Brukinsa achieved a significant benefit in a Phase 3 trial for patients with mantle cell lymphoma who received the drug as first‑line therapy. The s…
    Endpoints · 1mo agoPositive readoutPositive↗ 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
  • House panel launches probe into Bristol Myers and Pfizer's China trial sites
    A congressional committee has opened an inquiry into the use of clinical trial sites in China by Bristol Myers Squibb and Pfizer. The panel is focusing on facilities that the committee chair says…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • John Reed on J&J’s R&D model, oncology deals and pipeline expansion potential
    John Reed has overseen the pipelines of three of the largest drugmakers since leaving Southern California's Sanford Burnham medical research institute 13 years ago, giving him unique insight into h…
    Endpoints · 1mo ago↗ source
  • EU lobby urges member states to improve Europe’s life sciences sector
    More than 200 biopharma investors and firms have signed an open letter calling for European governments to improve Europe’s life sciences sector. The Friday letter was addressed to EU member states…
    Endpoints · 1mo ago↗ source
  • Zymeworks CEO on why the Theravance deal is value for money
    On the face of it, nearly $1 billion seems like a lot to spend on a biotech like Theravance. The company was clearly running out of steam, having twice downsized and been hit with repeated ...
    Endpoints · 1mo ago↗ source