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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 · 4h agoApprovalPositive↗ source
  • FDA expands Jazz's Ziihera use to frontline gastric cancer
    FDA granted approval for Jazz Pharmaceuticals' bispecific antibody Ziihera as a frontline treatment for certain gastric cancer patients. This is the first time Ziihera will be marketed to newly di…
    Endpoints · 8h agoApprovalPositive↗ source
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  • J&J’s Imaavy gains first-in-class label for warm autoimmune hemolytic anemia
    J&J announced that its monoclonal antibody Imaavy has received a label expansion in the United States. The expanded indication makes Imaavy the first therapy approved specifically for warm autoimm…
    Endpoints · 8h agoApprovalPositive↗ source
  • Eli Lilly launches oral obesity drug Foundayo in the UK
    Eli Lilly has introduced its oral weight‑loss pill Foundayo to the United Kingdom market, positioning the small‑molecule therapy as a price‑sensitive alternative to injectable options. The UK Medi…
    BioSpace · 11h agoRegulatoryPositive↗ source
  • Sword Health proposes acquisition of mental-health startup Headspace, linking two digital health unicorns
    Sword Health announced a proposal to acquire Headspace, a mental-health startup, according to a filing with Massachusetts state officials. The deal would combine two digital-health companies that…
    Endpoints · 1h agoDealNeutral↗ 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 · 8h agoRegulatoryNeutral↗ source
  • Haisco Pharmaceutical partners with ARCH Venture Partners and Population Health in new China-focused deal
    Haisco Pharmaceutical, a China-based drugmaker, has continued its active summer dealmaking by striking a new partnership. The partnership brings together ARCH Venture Partners, a venture capital f…
    Endpoints · 8h agoDealPositive↗ source
  • Haisco partners with US VCs to launch immunology biotech Sentivera with up to $1.5B funding
    Haisco Pharmaceutical Group announced the creation of a new immunology-focused biotech called Sentivera, backed by two American venture‑capital firms, Population Health Partners and ARCH Venture Pa…
    BioSpace · 9h agoDealPositive↗ 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 · 9h agoRegulatoryNegative↗ source
  • OmicsBank secures $2.25M to expand overseas patient data platform for biopharma
    OmicsBank announced it has closed a $2.25 million financing round aimed at scaling its platform that aggregates patient health data from overseas sources for use by biopharma companies. The compan…
    Endpoints · 10h agoDealPositive↗ 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 · 14h agoRegulatoryNegative↗ source
  • Curium seeks FDA review of rival radioligand therapy to boost supply resilience against Novartis' Pluvicto
    Curium is preparing to challenge Novartis' dominant prostate cancer radioligand therapy, Pluvicto, by entering discussions with the FDA about reviewing its own PSMA‑directed Lu‑177 candidate. Nova…
    BioSpace · 19h agoRegulatoryNeutral↗ 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 · 2h agoDealNeutral↗ source
  • Baxter Recalls One Lot of 70% Dextrose Injection Over Stainless Steel Particulate Risk
    Baxter International announced a voluntary recall of a single lot of its 70% Dextrose Injection after detecting potential stainless steel particles in the solution. The presence of these particles…
    fda recalls · 3h agoCRLNegative↗ source
  • Amgen and academic centers discuss FDA pilot to accelerate first-in-human trials
    The U.S. Food and Drug Administration is working with industry and research institutions on a pilot program aimed at speeding first-in-human studies. The effort is intended to counter the rapid tim…
    Endpoints · 4h agoRegulatoryNeutral↗ 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 · 7h 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 · 9h 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 · 9h agoRegulatoryNeutral↗ source
  • Bausch + Lomb moves dry-eye eye drop to Phase 3 despite missing primary endpoint in Phase 2
    Bausch + Lomb reported results of a Phase 2 trial of its dual-action dry-eye eye drop, which combines 5% lifitegrast (the active ingredient in Xiidra) with perfluorohexyloctane (PHFO, sold as Miebo…
    BioSpace · 11h agoNegative readoutNeutral↗ 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 · 14h agoNeutral↗ source
  • Massachusetts biopharma employment slips 3.1% in 2025 as R&D jobs fall, while manufacturing rises
    A new MassBio industry snapshot shows that total biopharma employment in Massachusetts fell 3.1% in 2025, translating to roughly 3,600 fewer jobs compared with the previous year. The decline was m…
    BioSpace · 16h agoNeutral↗ source
  • Biotech IPOs approach ‘escape velocity’ barring yellow flags that could threaten rebound
    Twenty-five biotechs have used the IPO route to go public this year—with five of those debuts occurring this month alone. It’s the most IPOs since 2021, when the industry recorded 78 during the hei…
    BioSpace · 8h agoRegulatoryNeutral↗ 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 · 9h agoRegulatoryNegative↗ source
  • Bristol Myers Squibb ends partnership with Cellares, prompting the cell therapy maker to restructure
    Bristol Myers Squibb announced that it is terminating its collaboration with Cellares after completing a comprehensive evaluation of the partnership. The decision was driven by BMS’s assessment th…
    Endpoints · 11h agoDealNegative↗ 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 · 14h agoNegative↗ source