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  • 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
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fda recalls49
fda medwatch41
fda press28
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Psychiatry & CNS729
Ophthalmology428
Pain407
Endocrinology & Metabolism390
Infectious Disease367
  • 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
  • NIH's All of Us program taps clinical data-sharing networks to add thousands of EHR records
    The National Institutes of Health's All of Us research program announced a new method for gathering real-world health data by leveraging existing patient data-sharing networks that are typically us…
    STAT · 1mo agoPositive↗ 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
  • 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 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
  • Investors increase stakes in Bain-backed biotech startup as FDA gene‑therapy chief departs
    Investors are putting more money into a biotech startup backed by private‑equity firm Bain Capital, according to the STAT+ newsletter. Vijay Kumar is leaving his role as acting director of the FDA…
    STAT · 1mo agoDealNeutral↗ source
  • US lawmakers probe Chinese clinical trial sites for potential military links involving major drugmakers
    A bipartisan group of U.S. lawmakers has launched a national‑security investigation into whether several large pharmaceutical companies participated in clinical trials at Chinese sites that may hav…
    STAT · 1mo agoRegulatoryNeutral↗ 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
  • 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
  • FDA digital chief signals upcoming AI regulatory guidance
    STAT+ health-tech newsletter reported that the FDA’s digital leader offered a preview of forthcoming guidance on artificial intelligence. The briefing, delivered by Rick Abramson, highlighted the a…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Half of U.S. states file lawsuits challenging Medicaid work-requirement rules
    A coalition of states has filed legal challenges against recent Medicaid work‑requirement policies, arguing that the rules threaten access to health coverage for low‑income residents. The lawsuits…
    STAT · 1mo agoRegulatoryNegative↗ 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
  • STAT+: Even with MAHA, Trump administration has gone soft on alcohol
    A STAT investigation has found that the Trump administration has downplayed alcohol’s risks and actively derailed efforts to understand and prevent drinking-related harms.
    STAT · 1mo ago↗ source
  • Opinion: Florida is the first state to require EKGs for high school athletes. It’s a mistake
    “There are better ways for schools to protect student athletes,” writes Katherine Hofmann.
    STAT · 1mo ago↗ source
  • STAT+: The loophole in Trump’s obesity drug deal with Eli Lilly and Novo Nordisk
    The Trump administration's grand bargain with drugmakers isn't working out as planned.
    STAT · 1mo ago↗ source
  • Opinion: Short-sighted new student loan caps elevate chiropractic care over critical health care professions
    “This administrative logic is hopelessly out of touch with the empirical reality of American health care,” writes David S. Shapiro.
    STAT · 1mo ago↗ source
  • STAT+: Abivax seeks to ease safety concerns with new data, boosting shares
    Safety concerns tied to Abivax's experimental bowel disease drug tanked company shares just weeks ago. But a new analysis sent them climbing.
    STAT · 1mo ago↗ source
  • STAT+: FDA’s top gene therapy regulator is leaving his role
    The departure of Vijay Kumar follows a broader leadership shakeup at the FDA.
    STAT · 1mo ago↗ source
  • STAT+: AstraZeneca to pay $34 million to settle kickback charges filed by Texas attorney general
    AstraZeneca agreed to pay $34 million to settle claims that the company paid kickbacks to improperly influence prescriptions paid for by Texas Medicaid.
    STAT · 1mo ago↗ source
  • FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing
    FDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufac…
    fda press · 1mo ago↗ source
  • STAT+: 26 states sue to block Medicaid work requirements
    States argue the rules will make it too hard for people to get the Medicaid coverage they're entitled too.
    STAT · 1mo ago↗ source
  • 5 takeaways from STAT’s investigation into microhospital operator Nutex Health
    Read the takeaways from STAT's investigation into Nutex, which used the No Surprises Act to fuel a stunning financial turnaround.
    STAT · 1mo ago↗ source
  • STAT+: Unredacted comments from California hospital lawsuits show stunning admissions and a ‘forced’ McKinsey collaboration
    Who controls the Medicaid market, GLP-1 usage and pizza household costs, and more from Health Care Inc.
    STAT · 1mo ago↗ source