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  • 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
  • Medicare proposes 33% cut to 340B drug payments for hospitals
    Medicare has released a proposal to cut payments to hospitals for drugs bought through the 340B discount program by more than a third. Under the plan, Medicare would reimburse hospitals at the aver…
    STAT · 1mo agoRegulatoryNegative↗ source
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fda recalls49
fda medwatch41
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918
Psychiatry & CNS727
Ophthalmology425
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Endocrinology & Metabolism390
Infectious Disease364
  • Lawmakers ask HHS to compel Eli Lilly to resume 340B hospital discounts
    A bipartisan group of congressional lawmakers has written to HHS Secretary Robert F. Kennedy Jr., urging the department to require Eli Lilly to restore 340B drug discounts for hospitals. Lilly hal…
    STAT · 1mo agoRegulatoryNegative↗ source
  • U.S. Judge Blocks Colorado Panel’s Attempt to Cap Amgen’s Enbrel Price
    A federal judge in the United States issued an order that prevents a Colorado state panel from imposing a price cap on Amgen’s blockbuster arthritis drug Enbrel. The ruling effectively blocks the s…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Federal judge halts Colorado price cap on Amgen's Enbrel drug
    A U.S. district judge issued an injunction that stops the Colorado Prescription Drug Affordability Board from imposing a payment limit on Enbrel, a high-volume biologic sold by Amgen. The court fou…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Former FDA AI regulator says biopharma is misreading agency's guidance, leading to overly cautious approaches
    Tala Fakhouri, who wrote AI policy at the FDA, left the agency last summer and now serves as chief AI and regulatory strategy officer at contract research organization Parexel. She says biopharma…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Genetix, formerly Bluebird Bio, claims rapid turnaround and aims to treat 1,000 sickle-cell patients annually by 2030
    David Meek completed a distressed buyout of Bluebird Bio last year and has rebranded the company as Genetix. He says the transaction rescued the firm from the brink of bankruptcy and set it on a pa…
    STAT · 1mo agoDealPositive↗ source
  • Elevance Health sues CMS, claiming $115 million loss from disputed Medicare Advantage star rating recalculation
    Elevance Health filed a lawsuit in the U.S. District Court for the Southern District of Georgia, alleging that the Centers for Medicare & Medicaid Services (CMS) recalculated its Medicare Advantage…
    STAT · 1mo agoRegulatoryNegative↗ source
  • CDC leadership accused of stifling vaccine effectiveness studies and reshaping advisory committee role
    Ben Lopman, a professor of epidemiology and global health at Emory University, wrote an opinion piece warning that CDC leadership is trying to manufacture a scientific debate about vaccines where n…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Hamilton Medical issues updated use instructions for certain breathing circuit sets after serious recall
    Hamilton Medical has sent a letter to customers on May 18, 2026, advising updated use instructions for specific coaxial breathing circuit sets used with its HAMILTON-C1, HAMILTON T-1 and HAMILTON-M…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Protillion Biosciences appoints Robert Hollingsworth as chief scientific officer
    Protillion Biosciences announced the hiring of Robert Hollingsworth as its new chief scientific officer. Hollingsworth joins Protillion after serving as chief scientific officer at Shoreline Therap…
    STAT · 1mo agoNeutral↗ source
  • Loss of Colorado Rep. Diana DeGette removes a knowledgeable voice for biopharma in Congress
    Colorado Democratic Rep. Diana DeGette was defeated in her primary, ending her service in the U.S. House of Representatives. DeGette was widely recognized for her deep understanding of biopharma p…
    STAT · 1mo agoNegative↗ source
  • Teen use of AI mental-health chatbots jumps 40% in a year, experts call for safety rules
    A recent study published in JAMA Pediatrics found that the proportion of adolescents turning to AI chatbots for mental-health advice rose from roughly one in eight to one in five within a single ye…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Heat waves become more frequent and intense, raising health risks for Americans as presidential fitness test returns
    Recent data show that heat waves across the United States are occurring more often, lasting longer, and reaching higher temperatures, which experts say could increase health problems such as heat e…
    STAT · 1mo agoNeutral↗ source
  • Presidential fitness test returns as a modest push for youth activity, experts caution limits
    The health secretary reintroduced a presidential fitness test as part of a campaign to boost youth health and address rising sedentary habits. Experts say the test is a positive step but not a com…
    STAT · 1mo agoNeutral↗ source
  • Study finds statins and blood-pressure meds bring middle-aged obese adults' heart risk markers in line with normal-weight peers
    A new 25-year observational study published in The Lancet shows that adults over 40 with obesity have blood‑pressure and cholesterol levels comparable to those of normal‑weight individuals. Resear…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Researchers claim creation of first fully synthetic cell, launch public benefit corporation to share technology
    Researchers at the University of Minnesota reported in a preprint that they have built what they call a synthetic cell, dubbed "SpudCell," which they suggest may be the first of its kind. The team…
    STAT · 1mo agoPositive↗ source
  • Anthropic launches Claude Science AI tool for pharma research labs
    Anthropic announced the availability of Claude Science, an application that tailors its large language model for use in scientific laboratories and pharmaceutical research operations. The tool is…
    STAT · 1mo agoPositive↗ source
  • Anthropic’s Claude Science signals AI firms are taking health research seriously
    Brittany Trang, a health‑tech reporter, notes that Anthropic’s new Claude Science model shows major AI developers are turning toward genuine scientific work rather than only high‑profile demos. Th…
    STAT · 1mo agoPositive↗ source
  • STAT+: More signs that GLP-1s may help with peripheral artery disease
    Anthropic will begin developing drugs, BridgeBio pockets a billion, and more biotech news from The Readout
    STAT · 1mo ago↗ source
  • FDA says Zyn can market its pouches as safer than cigarettes
    The influence of the alcohol industry on policy, AI Claude for scientists, and more health news from Morning Rounds
    STAT · 1mo ago↗ source
  • STAT+: FDA approves Orca Bio’s T cell therapy for blood cancer patients
    The FDA approved a T-cell therapy from Orca Bio that reduces the risk of a debilitating immune reaction in patients with blood cancers undergoing stem cell transplants.
    STAT · 1mo ago↗ source
  • STAT+: Booze schmooze: The alcohol industry, frazzled by headwinds, wields its power behind the scenes
    Demand for alcohol is declining. The industry is fighting harder and more creatively than ever against limits — and winning.
    STAT · 1mo ago↗ source
  • STAT+: The biotech scorecard for the third quarter: 15 stock-moving events to watch
    Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the third quarter.
    STAT · 1mo ago↗ source
  • Opinion: Maryland Gov. Wes Moore: How to improve young men’s mental health
    “We need to stop treating our young men and boys as problems to be solved, and start treating them as people to be invested in,” writes Gov. Wes Moore.
    STAT · 1mo ago↗ source