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1,106 stories matching this filter · ← front page

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  • Compass Pathways reports six-month durability of response in pivotal psilocybin depression trial
    Compass Pathways announced that patients in the second of its two pivotal psilocybin trials for depression continued to show a therapeutic response for at least six months. The durability data sugg…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Fresenius Kabi urges removal of dropped Ivenix infusion pumps after safety correction
    Fresenius Kabi has issued a safety notice for its Ivenix large-volume infusion pumps. The FDA classified the issue as a Class I recall, the most serious level, because the touchscreen can become un…
    fda medwatch · 1mo agoCRLNegative↗ source
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  • Digital health firms eye CMS ACCESS Medicare pilot despite modest reimbursement
    A new Medicare initiative called CMS ACCESS is being launched to manage chronic diseases among seniors. The program will contract digital health companies to provide remote monitoring and other se…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Cyllene Therapeutics raises €33 million to pursue HSV-based gene therapy after Krystal model
    Cyllene Therapeutics, a French-US biotech, announced it has secured €33 million in financing. The capital will be used to develop HSV-based gene therapy programs, aiming to replicate the approach…
    Endpoints · 1mo agoDealPositive↗ source
  • Vertex to acquire Crinetics in $10 billion deal to expand endocrinology portfolio
    Vertex Pharmaceuticals announced it will acquire Crinetics Pharmaceuticals for $10 billion, the largest purchase in the company's history. The transaction is aimed at broadening Vertex's commercia…
    Endpoints · 1mo agoDealPositive↗ source
  • AbbVie completes $10.9 billion acquisition of Apogee Therapeutics as UK launches drug pricing pilot
    AbbVie, the Chicago-based pharmaceutical company, finalized its purchase of Apogee Therapeutics for $10.9 billion last month, ending a multi-year negotiation process. The transaction brings Apogee…
    Endpoints · 1mo agoDealPositive↗ source
  • FDA approves 23 new drugs in first half, marking best pace in three years despite staff cuts
    The FDA announced that it has approved 23 novel drugs during the first half of 2026, the strongest approval count in three years. The approvals come after the Trump administration reduced FDA staf…
    Endpoints · 1mo agoApprovalPositive↗ source
  • CMS proposes rule to slash Medicare 340B drug payments by over a third
    CMS announced a proposed rule that would reduce the rates Medicare uses to reimburse hospitals for drugs purchased through the 340B program. The reduction would be more than one-third, effectively…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Novartis to spend $1.1 billion upfront acquiring Myricx Bio and its next-gen ADC platform
    Novartis announced Monday it will invest $1.1 billion in an upfront payment to acquire Myricx Bio. Myricx Bio brings an antibody-drug conjugate (ADC) payload platform that the Swiss group believes…
    Endpoints · 1mo agoDealPositive↗ source
  • Bristol Myers reports Krazati confirmatory trial fails in colorectal cancer
    Bristol Myers Squibb disclosed that the confirmatory study of its investigational drug Krazati in combination with an EGFR inhibitor did not achieve its primary efficacy endpoints in patients with…
    Endpoints · 1mo agoCRLNegative↗ source
  • Roche partners with Otsuka's Astex in $25 million deal to strengthen breast cancer pipeline
    Roche's Genentech subsidiary has signed a collaboration with Astex Pharmaceuticals, a unit of Otsuka, that includes a $25 million upfront payment. The partnership is an early‑stage effort aimed at…
    Endpoints · 1mo agoDealPositive↗ source
  • Windstone Medical issues correction for non-sterile alcohol prep pads in custom convenience kits
    Windstone Medical Packaging, Inc. has released a correction notice for several custom convenience kits that include Cardinal Health Webcol large alcohol prep pads that were found to be non-sterile.…
    fda medwatch · 1mo agoCRLNegative↗ source
  • FDA CDER appoints veteran GLP-1 reviewer Lisa Yanoff as acting deputy director
    Acting FDA CDER director Michael Davis promoted Lisa Yanoff to the role of acting deputy director of the Center for Drug Evaluation and Research. Yanoff is a long‑time FDA employee with deep exper…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Salk Institute President Warns of NIH Funding Cuts While Embracing AI and Brain Research Initiatives
    Gerald Joyce, president of the Salk Institute, highlighted recent reductions in NIH funding and their impact on research institutions. He said the institute is fully committing resources to artifi…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Anthropic unveils Claude Science platform as US House panel investigates Chinese clinical trial sites
    Anthropic, an artificial‑intelligence startup, announced the launch of Claude Science, a version of its Claude model built for scientific research. The new platform offers tools to help researchers…
    Endpoints · 1mo agoNeutral↗ source
  • Cadence raises $100M Series C to advance clinical AI for autonomous medical care
    Cadence, a health tech startup, announced a $100 million Series C financing round aimed at expanding its artificial intelligence platform. The new capital will support development of AI tools that…
    Endpoints · 1mo agoDealPositive↗ source
  • Vertex's Casgevy gene therapy receives FDA approval for children with sickle cell disease and beta-thalassemia
    Vertex announced that its gene therapy Casgevy has been granted FDA approval for use in pediatric patients. The decision expands the therapy's reach beyond adult indications. Casgevy is now author…
    Endpoints · 1mo agoApprovalPositive↗ source
  • Roche's KRAS G12C inhibitor divarasib outperforms Amgen and Bristol Myers Squibb drugs in Phase 3 head-to-head trial
    Roche announced that its KRAS G12C inhibitor divarasib showed superiority over existing marketed therapies from Amgen and Bristol Myers Squibb in a Phase 3 head-to-head trial in lung cancer. The t…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • AstraZeneca signs up to $1.7 billion R&D pact with China’s CSPC, marking second deal in six months
    AstraZeneca announced a new research collaboration with Chinese partner CSPC, valued at up to $1.7 billion. The agreement follows a previous large biobucks deal signed less than six months earlier…
    Endpoints · 1mo agoDealPositive↗ source
  • Abiomed recalls Impella CP Sets with SmartAssist over low purge pressure risk
    Abiomed has issued a recall of specific Impella CP Sets with SmartAssist after discovering that the units do not meet design specifications. The defect can cause low purge pressure events from the…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Scribe Therapeutics files for Nasdaq IPO, testing market appetite for early-stage gene-editing firms
    Scribe Therapeutics announced it has filed a registration statement to list its shares on the Nasdaq, marking the company’s first step toward a public offering. The filing highlights the growing i…
    Endpoints · 1mo agoDealNeutral↗ source
  • Colorado judge blocks 70% price cap on Amgen's Enbrel, citing potential economic injury
    A U.S. District Court in Colorado issued a preliminary injunction that stops a state‑imposed 70% price cap on Amgen's autoimmune drug Enbrel. The ruling was made by Judge Daniel Domenico, who grant…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Revolution Medicines reports promising early data for KRAS drug combo, plans Phase 3 in pancreatic cancer
    Revolution Medicines presented early-stage results that support moving forward with a Phase 3 study of a combination of two KRAS-targeted agents in pancreatic cancer. The data, shown for the first…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Otsuka presents long-term Phase 3 data for Voyxact, aiming to secure full FDA approval for kidney disease
    Otsuka announced new long-term results from the Phase 3 trial of its kidney disease drug Voyxact. The data show that the therapy stabilized kidney function over an extended period, building on ear…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Celea Therapeutics secures $180M financing to advance IPF pipeline
    Celea Therapeutics, an idiopathic pulmonary fibrosis (IPF) biotech, announced it has raised $180 million from a group of new investors. The funding is intended to help the company follow the devel…
    Endpoints · 1mo agoDealNeutral↗ source