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  • 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
  • ACA enrollment falls sharply, with Ohio and Oklahoma each losing about a third of participants
    New federal data shows steep drops in Affordable Care Act enrollment across the United States, with Ohio and Oklahoma each losing nearly one‑third of their participants. Overall, about 2.6 million…
    STAT · 1mo agoRegulatoryNegative
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Infectious Disease364
↗ source
  • Ebola therapy development accelerates as multiple candidates enter early trials
    A new wave of research teams are racing to develop a therapy for Ebola, according to the latest Morning Rounds newsletter. The article notes that several candidates are now moving into early‑stage…
    STAT · 1mo agoNeutral↗ source
  • GOP lawmakers urge FDA under Trump to enforce diversity in clinical trial enrollment
    Republican members of Congress have asked the Food and Drug Administration, now led by President Trump, to adopt policies that require clinical trials to enroll participants who reflect the diversi…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Physicians overuse diagnostic tests, urging structural changes to curb waste and antibiotic resistance
    American medicine orders more than 14 billion diagnostic tests each year, but many are performed at the wrong time or on patients who will not benefit. The author argues that while the industry ha…
    STAT · 1mo agoNegative↗ source
  • Vidcon highlights mental-health challenges faced by social video creators
    Vidcon this year devoted a significant portion of its programming to the mental health of content creators, reflecting growing concern about the pressures of online fame. In a STATus Report interv…
    STAT · 1mo agoNeutral↗ 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
  • 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
  • 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
  • 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
  • STAT+: Roche drug sets new standard for KRAS-driven lung cancer
    Biotech's bull market, Vertex's gene therapy expansion, and more news from The Readout
    STAT · 1mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about a court win for Amgen, Novo seeking supplier discounts, and more
    U.S. judge blocked a Colorado state panel from placing a cap on the price of Amgen's blockbuster drug Enbrel
    STAT · 1mo ago↗ source
  • STAT+: U.S. judge blocks Colorado’s first-of-its-kind price cap on an Amgen drug
    A federal judge blocked a Colorado state panel from placing a cap on the price of Enbrel, a blockbuster drug sold by Amgen
    STAT · 1mo ago↗ source
  • STAT+: More frequent, more intense, and longer heat waves pose health risks for Americans
    The presidential fitness test is back, surprising new data on the health risks of obesity, and more Morning Rounds news
    STAT · 1mo ago↗ source
  • STAT+: Halfway into the year, biotech is booming
    The biotech stock rally that began in April 2025 has not stopped, and if anything, has accelerated.
    STAT · 1mo ago↗ source
  • Opinion: Teens are turning to chatbots for mental health help. We need rules to keep them safe
    The share of young people using AI chatbots for mental health advice rose more than 40% in a single year, researcher writes.
    STAT · 1mo ago↗ source
  • Opinion: CDC leadership continues to try to manufacture a scientific debate on vaccines where none exists
    CDC leadership continues to try manufacture a scientific debate on vaccines where none exists, writes Ben Lopman.
    STAT · 1mo ago↗ source
  • STAT+: A former AI regulator, now in industry, says biopharma is reading FDA’s guidance wrong
    Companies are being too conservative in how they interpret FDA's AI guidance, but the agency can do more to help, too, Tala Fakhouri says.
    STAT · 1mo ago↗ source
  • STAT+: A year after distressed buyout, what’s become of Bluebird Bio?
    Bluebird Bio was a dark biotech morality tale when David Meek bought it. He says the new company, Genetix, is already making money.
    STAT · 1mo ago↗ source
  • The new presidential fitness test is a positive step, not the solution, experts say
    Physical activity needs to be fun to keep kids engaged. And the test risks embarrassing them, instead.
    STAT · 1mo ago↗ source
  • STAT+: A ‘historic’ FDA clearance raises the question: Is the LLM an interface or the decision-maker?
    The newly cleared device is based around an app that helps a patient manage their diabetes using a treatment plan defined by their doctor.
    STAT · 1mo ago↗ source
  • Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist
    Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case
    fda medwatch · 1mo ago↗ source
  • Breathing Circuit Set Correction: Hamilton Medical Updates Use Instructions for Breathing Circuit Set
    The ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation.
    fda medwatch · 1mo ago↗ source
  • Statins and blood pressure drugs changing health risks of obesity, study suggests
    New research shows obesity patients over 40 are managing blood pressure and cholesterol as well as healthy-weight peers, but younger adults remain at risk.
    STAT · 1mo ago↗ source