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  • OB-GYN draws parallels between ICU cries and whale songs in reflective essay
    Caroline Cherston, a fellow in reproductive endocrinology and infertility, uses an opinion piece to explore how human grief can sound like the songs of whales. She recalls a childhood nightmare of…
    STAT · 1d agoNeutral↗ source
  • Roche and Eli Lilly receive FDA clearance for first blood test detecting Alzheimer’s biomarker pTau217
    Roche and Eli Lilly have secured FDA clearance for a new blood test that measures phosphorylated tau protein pTau217, a marker linked to amyloid plaques in Alzheimer’s disease. The Elecsys pTau217…
    Fierce Biotech · 2d agoApprovalPositive↗ source
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Infectious Disease380
  • Roche signs $2.5 billion deal with Hanmi for experimental obesity drug targeting muscle loss
    Roche's Genentech unit has agreed to acquire global rights (outside South Korea) to Hanmi's clinical-stage urocortin-2 analog, HM17321, as part of a deal valued up to $2.5 billion. The agreement i…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Moderna and Merck report promising results from cancer vaccine amid early skepticism
    Moderna and Merck say their experimental mRNA cancer vaccine has produced encouraging mid‑stage data, shifting the narrative from doubt to optimism. At a March 2023 leadership meeting, executives…
    STAT · 2d agoPositive readoutPositive↗ source
  • FDA places clinical hold on Regenxbio’s RGX-121 gene therapy after spine MRI findings, delaying refiling plans
    The U.S. Food and Drug Administration has issued a clinical hold on Regenxbio’s gene therapy candidate RGX-121 after routine MRI scans revealed asymptomatic changes in the spines of trial participa…
    Fierce Biotech · 2d agoRegulatoryNegative↗ source
  • FDA alerts users to destroy AVID Medical IV start kits containing recalled BD ChloraPrep applicators due to fungal contamination risk
    The FDA's Center for Devices and Radiological Health issued an Early Alert warning that certain AVID Medical convenience kits may pose a high‑risk fungal contamination problem because they contain…
    fda medwatch · 2d agoRegulatoryNegative↗ source
  • Massachusetts biotech sees record-first-half VC funding and IPO surge despite modest NIH funding dip
    The latest MassBio Industry Snapshot reports a strong start to 2026 for the state’s biotech sector, with venture capital inflows rising 25% year over year to $3.45 billion in the first half of the…
    Fierce Biotech · 1d agoPositive↗ source
  • 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 · 1d 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 · 1d agoRegulatoryNegative↗ source
  • Qiagen names Jonathan M. Pratt as new chief executive after nine-month search
    Qiagen announced that Jonathan M. Pratt will take over as chief executive, ending a nine‑month search for a successor. Pratt arrives from Filtration Group, where he served as president and CEO. He…
    Fierce Biotech · 2d agoNeutral↗ source
  • TME Pharma narrows licensing talks for brain-cancer drug NOX-A12, eyes $1 billion market
    TME Pharma, a German biotech, says it has narrowed potential partners for its experimental glioblastoma therapy NOX-A12, a CCL2 inhibitor, to two firms and entered a final evaluation phase. The co…
    Fierce Biotech · 2d agoDealNeutral↗ source
  • Spruce Biosciences advances toward Q4 FDA filing for ultra-rare Sanfilippo B therapy
    Spruce Biosciences reported progress toward filing its enzyme replacement therapy, tralesinidase alfa (TA-ERT), for Sanfilippo syndrome type B, an ultra-rare lysosomal disorder. The company said t…
    Fierce Biotech · 2d agoRegulatoryPositive↗ source
  • 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 · 2d 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 · 2d agoRegulatoryNegative↗ source
  • FDA issues early alert on CooperSurgical infant nasal CPAP devices with loose tubing connection
    The FDA’s Center for Devices and Radiological Health has posted an Early Alert about a potential high-risk issue with certain CooperSurgical infant nasal CPAP devices. The problem involves a loose…
    fda medwatch · 2d agoRegulatoryNegative↗ source
  • FDA alerts to potential fungal contamination in Medline kits containing recalled BD ChloraPrep applicators
    The Center for Devices and Radiological Health (CDRH) has issued an Early Alert to warn the public about a possible high-risk device problem involving Medline convenience kits. Medline has sent a…
    fda medwatch · 2d 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 · 1d 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 · 1d 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 · 1d agoNegative↗ source
  • Early Alert: Nitric Oxide Delivery System Issue from NOxBOX
    The NOxBOX NOxBOXi System may leak oxygen during inhaled nitric oxide therapy
    fda medwatch · 2d agoRegulatoryNeutral↗ 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 · 2d 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 · 2d 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 · 2d 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 · 2d agoNeutral↗ source
  • Texas lawmaker warns Chinese biotech firms gaining early-stage advantage over U.S. industry
    Rep. Nathaniel Moran, a Republican from Texas and member of the House Select Committee on China, told Fierce that the United States is overlooking how Chinese biotech companies are outpacing Americ…
    Fierce Biotech · 2d agoNeutral↗ source