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2,186 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo agoApprovalPositive↗ source
  • Novartis to buy Myricx Bio for up to $1.5 billion, adding two novel ADCs to its oncology portfolio
    Novartis announced it will acquire Myricx Bio, a UK‑based biotech that develops antibody drug conjugates (ADCs), in a move to broaden its oncology pipeline. The transaction is valued at up to $1.5…
    BioPharma Dive · 4mo agoDealPositive↗ 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 · 4mo agoRegulatoryNegative↗ source
  • Cancer and immune-focused biotech firms capture over $3.9 billion of H1 2026 venture capital
    BioPharma Dive data show that cancer and immune disease biotech companies accounted for more than 40% of the biotech firms receiving venture funding in the first half of 2026. Of the roughly $9 bi…
    BioPharma Dive · 4mo agoDealNeutral↗ 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 · 4mo 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 · 4mo 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 · 4mo agoDealPositive↗ source
  • Gene-editing biotech Scribe Therapeutics files for Nasdaq IPO
    Scribe Therapeutics, a California-based biotechnology startup developing genetic medicines for cardiometabolic disorders, announced plans to go public on the Nasdaq under the ticker SCTX. The comp…
    BioPharma Dive · 4mo agoDealNeutral↗ 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 · 4mo agoCRLNegative↗ source
  • Lancaster County emerges as new biotech hub as Boston faces layoffs
    Boston’s biotech sector is experiencing layoffs and vacant lab space, signaling a slowdown in the region that has long been a biotech stronghold. In contrast, Lancaster County, Pennsylvania, is wi…
    BioPharma Dive · 4mo agoNeutral↗ 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo agoDealPositive↗ source
  • Roche’s divarasib shows survival benefit over Amgen and BMS drugs in KRAS G12C lung cancer trial
    Roche reported that its experimental KRAS G12C inhibitor divarasib extended overall survival and progression‑free survival in a Phase 3 head‑to‑head study against Amgen’s Lumakra and Bristol Myers…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ 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 · 4mo 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 · 4mo 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 · 4mo agoDealPositive↗ source
  • Celea Therapeutics raises $180 million to advance next-generation IPF drug deupirfenidone
    Celea Therapeutics, a PureTech Health spinout, announced a $180 million venture round to fund development of its next-generation idiopathic pulmonary fibrosis (IPF) therapy, deupirfenidone. The ro…
    BioPharma Dive · 4mo agoDealPositive↗ source