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  • Venture funding for women’s health startups drops sharply after 2024 peak, AI may drive rebound
    Venture capital flowing into women’s health companies fell sharply after reaching record levels in 2024. A Silicon Valley Bank report shows total funding dropped from about $3.2 billion in 2024 to…
    BioPharma Dive · 13d agoNeutral↗ 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 · 13d agoRegulatoryNegative↗ source
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  • 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 · 13d agoRegulatoryNeutral↗ 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 · 13d 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 · 13d 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  • FDA releases draft guidance on potency testing for immunotherapy products
    The FDA’s Center for Biologics Evaluation and Research (CBER) has issued a draft guidance document aimed at helping sponsors evaluate potency assays for active immunotherapy products (ACTIMPs).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 · 13d 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 · 13d 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 · 13d 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 · 13d 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 · 13d agoPositive↗ source
  • Inhalable modified tRNA restores lung protein function in cystic fibrosis mice, shows promise for genetic diseases
    University of Toronto scientists have shown that an inhalable form of modified transfer RNA can safely reach the lungs of mice carrying a nonsense mutation that causes cystic fibrosis. The treatmen…
    Fierce Biotech · 13d agoPositive readoutPositive↗ 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 · 13d 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 · 13d agoNegative readoutNeutral↗ 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 · 13d 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 · 13d 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 · 13d agoNeutral↗ source
  • Massachusetts biotech startups see funding gap widen as seed rounds shrink and Series A deals surge
    A MassBio report shows that mature biotech firms in Massachusetts captured most of the venture capital in the first half of 2026, with nearly $3.5 billion invested, a 25% rise from the same period…
    BioPharma Dive · 13d 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 · 13d agoRegulatoryNegative↗ source
  • Frontier Medicines CEO vows to accelerate cancer drug pipeline after recent layoffs
    Frontier Medicines announced that after a restructuring that included layoffs last year, the company is refocusing on its AI-driven proteomics platform to push more cancer therapies into clinical t…
    Fierce Biotech · 13d agoPositive↗ 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 · 13d 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 · 13d 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 · 13d 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 · 13d 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 · 13d 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 · 13d agoNeutral↗ source