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  • 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
  • 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
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  • 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
  • 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
  • Sandoz launches direct-to-consumer platform with growth disorder drug
    Sandoz unveiled a direct-to-consumer platform, starting off with a single medication for now as the generic drugmaker adopts a system that several brand-name manufacturers are using to cut out-of-p…
    Endpoints · 1mo ago↗ source
  • After landmark deal, AstraZeneca goes to CSPC again in up to $1.7B pact
    Less than six months after lining up one of the largest biobucks packages in industry history, AstraZeneca is returning to the same Chinese partner for another drug R&D collaboration. The UK pharma…
    Endpoints · 1mo ago↗ source
  • Court halts Colorado price cap on Amgen's blockbuster Enbrel
    US District Court Judge Daniel Domenico in Colorado granted Amgen's preliminary injunction to stop a 70% price cap on its blockbuster autoimmune drug Enbrel, arguing that the cap could cause "econo…
    Endpoints · 1mo ago↗ source
  • Revolution Medicines shares promising data around KRAS drug combination
    Revolution Medicines on Thursday gave a first look at the early-stage data that led it to plan a Phase 3 trial combining two KRAS drugs in pancreatic cancer. One of the two drugs is a ...
    Endpoints · 1mo ago↗ source
  • Otsuka reports long-term kidney data key to Voyxact's bid for full approval
    Otsuka on Thursday reported new long-term data that it hopes will convert an accelerated approval to a full green light in kidney disease. The company said the Phase 3 study showed Voyxact stabiliz…
    Endpoints · 1mo ago↗ source
  • IPF biotech Celea gets $180M to follow paths of PureTech's Karuna, Seaport
    With major backing from new investors, Celea Therapeutics hopes to follow in the footsteps of its siblings Seaport Therapeutics and Karuna Therapeutics. Celea has corralled $180 million to see if
    Endpoints · 1mo ago↗ source
  • Vertex's sickle cell therapy approved for kids; United Therapeutics buys startup
    🧬 Vertex’s sickle cell gene therapy approved for kids: Casgevy may now be used to treat either sickle cell disease with recurrent vaso-occlusive crises or transfusion-dependent β-thalassemia patie…
    Endpoints · 1mo ago↗ source
  • Galderma gets CRL for anti-wrinkle drug; Kimball buys CDMO for $103M
    Plus more from Lonza, Icosagen and others. 🟥 Galderma’s CRL: Galderma has received a complete response letter from the FDA for its relabotulinumtoxinA, a drug being reviewed as a neuromodulator to…
    Endpoints · 1mo ago↗ source
  • How Butterfly, once known for its handheld ultrasound device, is growing its chip-making business
    Nvidia got its start as a gaming chip maker before meteoric success selling its chips to nearly every industry. One health tech company is hoping to go down a similar route. Last month, ultrasound…
    Endpoints · 1mo ago↗ source