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  • Axiom's stem cell therapy shows zero mortality in phase-1 trial for newborn brain injuries
    Axiom Biosciences reported that its mesenchymal stem cell (MSC) therapy achieved a 0% mortality rate over two years in a phase‑1 study of newborns with severe brain injuries. The nine‑patient trial…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • New acting head Karim Mikhail seeks to steady FDA’s biologics center after turbulent leadership
    Karim Mikhail, the acting director of the FDA’s Center for Biologics Evaluation and Research, told staff in a town‑hall meeting that he understands the pressures they face and wants to work alongsi…
    STAT · 1mo agoRegulatoryPositive↗ source
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  • FDA Grants Emergency Use Authorization for Ivermectin Liquid to Prevent New World Screwworm in Horses
    The U.S. Food and Drug Administration has issued an Emergency Use Authorization for an ivermectin oral solution intended for horses, aimed at preventing infestations by New World screwworm. The au…
    fda press · 1mo agoRegulatoryNeutral↗ source
  • Elevance Health to Exit Unsustainable Medicaid Markets Over Next 12-18 Months
    Elevance Health, the nation's second-largest insurer, said on its Q2 earnings call it will further reduce its Medicaid business in the coming year. The move comes as several states are preparing t…
    STAT · 1mo agoNeutral↗ source
  • Uncertainty persists over food source of summer cyclospora outbreak, officials say
    A parasite called cyclospora has infected nearly 7,000 people across 34 states this summer, marking one of the largest surges on record. Michigan health officials have identified lettuce and salad…
    STAT · 1mo agoNegative↗ source
  • CDC reports surge in cyclosporiasis cases, over 1,600 confirmed in U.S.
    The Centers for Disease Control and Prevention has confirmed more than 1,600 cases of cyclosporiasis, a parasitic infection that causes diarrhea, across the United States. An additional 5,100 cases…
    STAT · 1mo agoNeutral↗ source
  • Mwyngil Therapeutics launches obesity program that avoids GLP-1 pathway
    Mwyngil Therapeutics, a newly formed biotech startup, is pursuing obesity treatments that do not target the GLP-1 receptor, a pathway that has dominated recent weight-loss drug development. CEO Lu…
    STAT · 1mo agoNeutral↗ source
  • Scientists and stakeholders overwhelmingly oppose White House grantmaking overhaul, analysis finds
    Researchers at the University of North Carolina at Chapel Hill, working with STAT, examined a flood of public comments on a White House proposal to revamp the federal "Uniform Guidance" that govern…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Senator Lindsey Graham's death from aortic dissection spotlights need for better screening
    Senator Lindsey Graham died at age 71 after suffering an aortic dissection, drawing public attention to this rare but deadly condition. An aortic dissection occurs when the body's main blood vesse…
    STAT · 1mo agoNegative↗ source
  • Ebola outbreak in eastern Congo accelerates, 80% of new cases from unknown transmission chains
    WHO emergencies chief Chikwe Ihekweazu said the Ebola outbreak in eastern Congo is outpacing response efforts, noting that many recent deaths occurred in communities without reaching health facilit…
    STAT · 1mo agoNegative↗ source
  • FTC settlement forces CVS Caremark to change insulin pricing, could save US patients $8.5 billion
    The Federal Trade Commission announced it has settled a lawsuit against CVS Caremark, one of the nation's largest pharmacy benefit managers, over claims the company inflated insulin prices and rest…
    STAT · 1mo agoRegulatoryPositive↗ source
  • 340B Drug Discount Program sales hit $100 billion in 2025, up 22.8% year over year
    The Health Resources and Services Administration reported that purchases under the 340B discount program reached $100 billion in 2025, a 22.8% rise from 2024. Expensive medicines made up a growing…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • HCA Healthcare cuts 2026 profit outlook as uninsured patient numbers rise after ACA subsidy expiration
    HCA Healthcare, the largest U.S. hospital chain, announced on Tuesday that it is lowering its profit outlook for 2026. The revision reflects a higher-than-expected number of uninsured patients in…
    STAT · 1mo agoNegative↗ source
  • Biogen’s experimental Alzheimer’s drug diranersen slows cognitive decline in Phase 2, matching approved therapies
    Biogen reported that its experimental Alzheimer’s therapy diranersen slowed cognitive decline in a mid-stage Phase 2 study, achieving decline rates similar to those seen with drugs already on the m…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Former FDA toxicologist says agency approved Zyn nicotine pouches without fully knowing their composition
    Former FDA toxicologist Christy Leppanen alleges the agency authorized Zyn nicotine pouches without complete safety data on the pouch material. Leppanen, who led a microplastics exposure project a…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Deepfake videos of doctors threaten trust in telehealth and digital care
    A patient recently presented a video that appeared to show her physician in a white coat, recommending an over‑the‑counter hormone supplement and disparaging standard treatments. The doctor confirm…
    STAT · 1mo agoNegative↗ source
  • Alcohol Use Remains Leading Cause of Death in U.S., New Data Highlights Hidden Epidemic
    STAT's latest series reveals that alcohol kills more Americans each year than all illicit drugs combined, yet it remains largely overlooked by health officials and the public. Ten charts illustrat…
    STAT · 1mo agoNegative↗ source
  • AI competition shows better data beats larger models in drug metabolism predictions
    Inductive Bio emerged as the winner of a recent drug metabolism AI competition, but the final standings revealed a 28-way statistical tie, underscoring that the quality of data can outweigh model s…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Experts say MDUFA VI draft letter improves program while addressing FDA resource limits
    Industry experts note that the draft commitment letter for the upcoming Medical Device User Fee Amendments (MDUFA VI) offers enhancements over the current framework and takes into account the FDA’s…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Anthropic launches Claude Science AI platform for biotech labs in Kendall Square
    Anthropic has introduced Claude Science, an application that tailors its large language model for use in biopharma research laboratories. The tool is being positioned for the Kendall Square biotech…
    STAT · 1mo agoNeutral↗ source
  • Former Akero executives team up with Fairmount to launch new immunology company
    The former executive team of Akero Therapeutics, which was recently acquired by Novo Nordisk, has announced the formation of a new immunology-focused company. They are partnering with investment fi…
    STAT · 1mo agoNeutral↗ source
  • US appeals court revives Teva lawsuit alleging Lilly breached generic Forteo agreement
    A U.S. appeals court has revived a lawsuit filed by Teva Pharmaceuticals against Eli Lilly. The case alleges that Lilly broke an agreement that permitted Teva to sell a generic version of Lilly's o…
    STAT · 1mo agoNegative↗ source
  • Cyclospora infections hit record high in 2026, Michigan officials suspect lettuce as source
    Infections caused by the parasite Cyclospora have surged to a record level in 2026, with more than 30 states reporting cases that now exceed the previous U.S. high of about 4,700 set in 2019. The…
    STAT · 1mo agoNegative↗ source
  • Democratic senators raise concerns over credibility and conflicts in RFK Jr.'s health-care advisory panel
    Two senior Democratic senators sent a letter to Health Secretary Robert F. Kennedy Jr. and CMS Administrator Mehmet Oz, saying they have serious concerns about the credibility and financial conflic…
    STAT · 1mo agoRegulatoryNegative↗ source
  • BIO 2026 in San Diego features executive interviews on biotech trends and opportunities
    The BIO International Convention gathered more than 20,000 life‑science leaders in San Diego, serving as a major forum for biotech discussion. During the event, Fierce conducted a series of video…
    Fierce Biotech · 1mo agoNeutral↗ source