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3,027 stories matching this filter · ← front page

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  • 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 · 2mo 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 · 2mo agoNeutral↗ source
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  • 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 · 2mo 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 · 2mo agoRegulatoryNegative↗ 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo agoNeutral↗ source
  • Jaime’s Foods ATX recalls Spanish Village Jalapeno Ranch dressing over undeclared egg allergen
    Jaime’s Foods ATX of Austin, Texas announced a recall of its Spanish Village Jalapeno Ranch dressing because the product contains undeclared eggs, posing a risk to individuals with egg allergies.…
    fda recalls · 2mo agoCRLNegative↗ source
  • Better Bakehouse recalls Donutful chocolate‑dipped vanilla cake donuts over undeclared milk allergen
    The Better Bakehouse Snack Company announced a recall of certain lots of its Donutful Chocolate Dipped Vanilla Cake Donuts because the product may contain undeclared milk, creating a serious risk f…
    fda recalls · 2mo agoCRLNegative↗ 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 · 2mo agoNeutral↗ source
  • Roche's Genentech signs up to $2.3B deal with Hanmi for weight-loss drug that preserves lean mass
    Roche, through its Genentech subsidiary, has entered a licensing agreement with South Korea's Hanmi Pharm that could be worth up to $2.3 billion, including a $190 million upfront payment. The deal…
    BioSpace · 2mo 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 · 2mo agoPositive readoutPositive↗ source
  • FDA places hold on REGENXBIO's Hunter syndrome gene therapy after spinal nodules found, company pauses resubmission
    The FDA placed a clinical hold on RGX-121, REGENXBIO's gene therapy for Hunter syndrome, after MRI scans showed small nodules or cystic masses in the spines of five trial participants. The finding…
    BioSpace · 2mo agoRegulatoryNegative↗ source
  • FDA grants three-month extension for Capricor’s Duchenne therapy deramiocel, sets new action date Nov 22
    The U.S. Food and Drug Administration has given Capricor Therapeutics a three‑month extension to review additional data for its Duchenne muscular dystrophy cell therapy, deramiocel. The agency has…
    BioSpace · 2mo agoRegulatoryNeutral↗ 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 · 2mo 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 · 2mo agoRegulatoryNegative↗ 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 · 2mo 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 · 2mo agoRegulatoryNegative↗ source
  • FDA’s new leadership aims to restore reliability, but each application remains judged on its data
    The FDA’s current leadership is working to rebuild the agency’s reputation for reliability, integrity and transparency after a turbulent period under former commissioner Marty Makary. Recent actio…
    BioSpace · 2mo agoRegulatoryNeutral↗ source
  • FDA clears Roche and Lilly Alzheimer’s blood tests, while Regenxbio gene therapy trial halted again
    The U.S. Food and Drug Administration announced it has granted clearance for blood-based diagnostic tests for Alzheimer’s disease developed by Roche and Eli Lilly. The clearances allow the compani…
    raps · 2mo agoRegulatoryNeutral↗ source
  • FDA asks industry input on competency-based rules for generative AI medical devices
    The FDA announced it is soliciting comments on a proposed competency-based framework for overseeing medical devices that incorporate generative artificial intelligence. The agency says the approac…
    raps · 2mo agoRegulatoryNeutral↗ 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 · 2mo 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 · 2mo agoRegulatoryNeutral↗ source