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  • Lady Gaga and fiancé announce new biotech startup as FTC eyes Amgen patents and Moderna-Merck vaccine advances
    Lady Gaga and her fiancé have announced the formation of a new biotech startup, marking a rare foray of a pop culture figure into the life‑science sector. The Federal Trade Commission has begun a…
    STAT · 4h agoNeutral↗ source
  • FDA pauses Regenxbio gene therapy trial for Hunter syndrome after spinal masses found
    The Food and Drug Administration has placed another hold on Regenxbio's gene-therapy trial for mucopolysaccharidosis type II, also known as Hunter syndrome, after new safety concerns emerged. Five…
    STAT · 7h agoRegulatoryNegative↗ source
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Infectious Disease373
  • FDA to Issue Formal Guidance on Regulating Generative AI Medical Devices
    The Food and Drug Administration announced that it is creating a plan to regulate medical devices that incorporate generative artificial intelligence. Rick Abramson, director of the agency’s Digita…
    STAT · 10h agoRegulatoryPositive↗ source
  • Trump administration rule bars Medicaid payment for pediatric gender-affirming meds, could set broader coverage precedent
    The Centers for Medicare & Medicaid Services released a final rule that prohibits the use of federal Medicaid and CHIP funds for pediatric gender-affirming medications and related surgeries. The ru…
    STAT · 10h agoRegulatoryNegative↗ source
  • Medicaid coverage for GLP-1 weight-loss drugs stalls, only Indiana signs on
    President Trump pledged to broaden Medicaid access to costly GLP-1 obesity medications by letting states negotiate prices directly with manufacturers. The rollout depended on state participation,…
    STAT · 5h agoRegulatoryNegative↗ source
  • FDA signals upcoming rules for generative AI use in drug development
    The FDA announced it intends to create regulatory guidance for the use of generative artificial intelligence in pharmaceutical research and development. The move follows growing interest in AI too…
    STAT · 6h agoRegulatoryNeutral↗ source
  • Aon warns 2027 will bring steep rise in employer health premiums, highlighting data gaps for public-sector plans
    Aon’s chief actuary warned that 2026 data points to a harsh 2027 for employer-sponsored health insurance premiums, with costs expected to rise sharply. The firm said employers will need better dat…
    STAT · 4h agoNegative↗ source
  • Study finds SNAP soda bans cut purchases by 12% among beneficiaries
    A new study shows that purchases of soda fell by roughly 12% among people receiving Supplemental Nutrition Assistance Program benefits after the bans on soda and candy took effect in ten states. Th…
    STAT · 14h agoRegulatoryPositive↗ source
  • Handshakes in the ER: A simple gesture can ease patient anxiety
    An emergency medicine resident at Northwestern University recounts a recent shift where a patient faced a suspected oncologic emergency. The physician introduced herself with a handshake to the pat…
    STAT · 10h agoPositive↗ source
  • Nurse practitioner students struggle to find clinical preceptors, often paying thousands
    Nurse practitioner graduate programs require students to complete at least 500 hours of supervised patient care with a licensed preceptor. Across the United States, a shortage of qualified precepto…
    STAT · 10h agoNegative↗ source
  • Retired cardiologist finds new purpose volunteering at Maryland community clinic, highlights gaps in US health care
    A cardiologist who spent nearly four decades in private practice retired in 2022 and soon after began volunteering at a nonprofit community clinic in Maryland. The clinic serves the "working poor"…
    STAT · 10h agoNeutral↗ source
  • Qiagen appoints new chief executive after 9-month search
    Molecular diagnostics specialist Qiagen has a new CEO as Jonathan M. Pratt takes the reins.
    Fierce Biotech · 8h ago↗ source
  • TME holds onto $1B dream for brain cancer drug as search for partners nears conclusion
    TME Pharma’s hunt for a partner for its brain cancer drug is closer to bearing fruit as the German biotech clings to its hope of generating $1 billion in peak sales from the asset.
    Fierce Biotech · 8h ago↗ source
  • Spruce’s successful FDA talks plant seeds for Q4 filing of ultra-rare disease drug
    Spruce Biosciences has taken another step toward filing for FDA approval of its ultra-rare disease drug candidate, ticking off some of the manufacturing tasks needed to submit the long-awaited appl…
    Fierce Biotech · 9h ago↗ source
  • STAT+: Inside Moderna and Merck’s cancer vaccine triumph
    Moderna and Merck's wild gambit on a cancer vaccine appears to have worked, despite big doubts, logistical challenges, and pandemic-era complications.
    STAT · 10h ago↗ source
  • Regenxbio gene therapy refiling plan derailed by FDA hold over spine MRI findings
    The FDA has put a clinical hold on Regenxbio’s RGX-121 over asymptomatic spine MRI findings, derailing the biotech’s plans to refile for approval of the once-rejected gene therapy candidate.
    Fierce Biotech · 11h ago↗ source
  • Roche, Eli Lilly net FDA approval for first-of-its-kind Alzheimer’s biomarker blood test
    Roche and Eli Lilly have won FDA clearance for their latest Alzheimer’s disease diagnostic.
    Fierce Biotech · 11h ago↗ source
  • Roche pens $2.5B pact for Hanmi’s clinical-stage obesity drug targeting less-explored mechanism
    Roche has taken its obesity strategy into uncharted territory via a $190 million upfront payment for a clinical-stage urocortin-2 analog from South Korea’s Hanmi Pharm.
    Fierce Biotech · 14h ago↗ source
  • Early Alert: Ventilator Issue from CooperSurgical
    The cannula sets may exhibit a loose connection between the flexible tubing and the nasal cannula resulting in reduced effectiveness and decreased oxygenation.
    fda medwatch · 15h ago↗ source
  • Early Alert: Nitric Oxide Delivery System Issue from NOxBOX
    The NOxBOX NOxBOXi System may leak oxygen during inhaled nitric oxide therapy
    fda medwatch · 15h ago↗ source
  • Early Alert: Convenience Kit Issue from AVID Medical
    Certain AVID Medical convenience kits containing recalled BD ChloraPrep applicators should be removed from use due to potential fungal contamination
    fda medwatch · 15h ago↗ source
  • Early Alert: Convenience Kit Issue from Medline
    Certain Medline convenience kits containing recalled BD ChloraPrep applicators should be removed from use due to potential fungal contamination
    fda medwatch · 15h ago↗ source
  • Cure for HIV must protect long-term survivors from loss of benefits
    The authors, a postdoctoral researcher, a long‑term HIV survivor, and the head of a survivor alliance, argue that a future HIV cure should not jeopardize the support systems that have kept many pat…
    STAT · 3d agoNeutral↗ source
  • Roche's Genentech to invest $750 million to double Oregon manufacturing site
    Roche's Genentech announced a $750 million investment to expand its existing production facility in Oregon, with the goal of doubling its capacity. The expanded site is expected to boost manufactu…
    STAT · 3d agoDealNeutral↗ source
  • HHS seeks public input on new vaccine recommendation categories under Trump and Kennedy
    A request for information was posted by the Department of Health and Human Services, giving the public a 30‑day window to comment on potential changes to the U.S. vaccine recommendation framework.…
    STAT · 3d agoRegulatoryNeutral↗ source