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  • FDA clears first wearable that continuously tracks both glucose and ketone levels
    The U.S. Food and Drug Administration has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for individuals aged two years and older who have diabetes. The device is…
    fda press · 12h agoApprovalPositive↗ source
  • Sentivera secures up to $1.5 billion licensing deal for inflammatory disease candidate
    Sentivera, a biotech startup formed by investors behind Metsera, announced a licensing agreement with Shanghai-listed Haisco Pharmaceutical. Under the deal, Sentivera will pay Haisco $40 million u…
    Fierce Biotech · 21h agoDealPositive↗ source
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Infectious Disease380
  • Implantica receives FDA approval for RefluxStop GERD implant after eight years since EU launch
    Implantica announced that the U.S. Food and Drug Administration has granted approval for its gastroesophageal reflux disease (GERD) implant, RefluxStop, following a rigorous Premarket Approval revi…
    Fierce Biotech · 1d agoApprovalPositive↗ source
  • Trump-era health funding cuts reshape U.S. health system, prompting Medicaid coverage changes
    STAT’s D.C. Diagnosis newsletter examines how recent Republican health‑care funding cuts are altering the nation’s health‑care safety net. The series, led by Washington correspondent John Wilkerson…
    STAT · 15h agoRegulatoryNeutral↗ source
  • Turkish antitrust regulator launches probe into Teva for alleged patent manipulation and false claims about rivals
    Turkish competition authorities have opened an investigation into Teva Pharmaceutical, the world’s largest generic drugmaker, accusing the company of manipulating the patent system and making misle…
    STAT · 16h agoRegulatoryNegative↗ source
  • Trump’s Medicaid cuts strain rural hospitals in Maine and Louisiana
    President Trump’s administration has slashed about $1 trillion from projected Medicaid funding over the next ten years and let billions in insurance subsidies expire, prompting a rapid reassessment…
    STAT · 22h agoRegulatoryNegative↗ source
  • FDA grants Capricor three-month extension to review DMD cell therapy data
    The U.S. Food and Drug Administration has given Capricor Therapeutics an additional three months to evaluate its Duchenne muscular dystrophy cell therapy after the agency asked for more information…
    Fierce Biotech · 1d agoRegulatoryNegative↗ source
  • FDA expands labels for J&J’s Imaavy and Jazz’s Ziihera; Teva under Turkish antitrust probe
    The U.S. Food and Drug Administration has broadened the approved uses for Johnson & Johnson’s oncology drug Imaavy and Jazz Pharmaceuticals’ Ziihera, adding new indications to each label. These la…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA releases draft guidance on potency testing for immunotherapy products
    The FDA’s Center for Biologics Evaluation and Research (CBER) has issued a draft guidance document aimed at helping sponsors evaluate potency assays for active immunotherapy products (ACTIMPs). Th…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA issues warning letters to drugmakers in China, India and the US over GMP violations
    The U.S. Food and Drug Administration has issued warning letters to a number of manufacturers in China, India and the United States. The letters cite multiple violations of good manufacturing prac…
    raps · 1d agoRegulatoryNegative↗ source
  • Sword Health to acquire mental-health platform Headspace in cash deal slated for September 14
    Sword Health, a digital health firm best known for its AI‑driven virtual physical therapy, has filed to purchase mental‑health service provider Headspace. The regulatory filing indicates the trans…
    STAT · 9h agoDealNeutral↗ source
  • Two unvaccinated Pennsylvanians die from measles, marking first US deaths this year
    Two unvaccinated residents of Lancaster County, Pennsylvania have died from measles, the first measles-related deaths reported in the United States this year. State Health Secretary Dr. Debra Boge…
    STAT · 14h agoNegative↗ source
  • Massachusetts biotech workforce rebounds after 2025 decline
    A new report from the Massachusetts Biotechnology Council shows the state’s biopharma employment fell by about 3,600 workers in 2025, marking the first drop since at least 2002. The workforce tota…
    STAT · 16h agoPositive↗ source
  • FDA pledges new guidance for generative AI medical devices as Epic shares updates from its user conference
    The Food and Drug Administration released a discussion paper outlining its plans to regulate generative‑AI‑powered medical devices. The agency said it will issue formal guidance to clarify how exis…
    STAT · 16h agoRegulatoryNeutral↗ source
  • Labcorp introduces reflex hepatitis D test to improve detection of severe viral hepatitis
    Labcorp has launched a new hepatitis D (HDV) reflex testing option as part of its Comprehensive Hepatitis Testing portfolio, aiming to close a gap in HDV monitoring. The test automatically adds HD…
    Fierce Biotech · 19h agoPositive↗ source
  • AI can flag drug theft in hospitals, but alerts need human follow-up, case shows
    In September 2024, a travel nurse at Adventist Health in Bakersfield, California, was observed behaving erratically and was later found to be diverting opioids from a secured cabinet, documenting t…
    STAT · 22h agoNeutral↗ source
  • FDA issues warning letters to drug manufacturers in India, China and US over GMP violations
    The FDA has sent formal warning letters to several companies located in India, China and the United States. The letters cite multiple breaches of current good manufacturing practice standards in t…
    raps · 1d agoRegulatoryNegative↗ source
  • Senators say HHS Secretary RFK Jr.’s Gardasil stake explanation contradicts earlier testimony
    A group of U.S. senators have raised concerns about the explanation offered by Robert F. Kennedy Jr., the Health and Human Services secretary, regarding how he disposed of a financial interest tied…
    STAT · 17h agoRegulatoryNegative↗ source
  • Cancer screening guidelines overlook residents of long-term care facilities, expert warns
    Kim Johnson, a cancer epidemiologist at Washington University, reflects on the lack of screening guidance for people living in long‑term care after her aunt's death. Her aunt, 78, entered a care f…
    STAT · 22h agoNegative↗ source
  • Comments on OMB Research Rule Disappear from Government Site, Raising Transparency Concerns
    A federal website that hosted public comments on a proposed Office of Management and Budget research rule was found to have removed several submissions, according to a report. The rule under consi…
    STAT · 22h agoRegulatoryNegative↗ source
  • CDC reports US life expectancy rises to 79 years in 2024, surpassing pre-pandemic levels
    The CDC's National Center for Health Statistics released new life expectancy figures for 2024. Babies born in 2024 are projected to live to age 79, up 0.6 years from 2023 and 0.2 years above the 2…
    STAT · 18h agoNeutral↗ source
  • 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 · 22h 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 · 1d agoApprovalPositive↗ source
  • 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 · 1d agoPositive readoutPositive↗ source