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2,473 stories matching this filter · ← front page

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  • Study finds blocking T cells entry into brain slows neurodegeneration in mice
    Researchers at Washington University in St. Louis reported that preventing certain immune cells, specifically T cells, from entering the brain reduced signs of neurodegeneration in a mouse model.…
    STAT · 21d agoPositive↗ source
  • Child health crisis threatens US national security, authors warn
    The authors argue that chronic illness, anxiety, depression and other health problems among children undermine future military readiness, the workforce and the nation’s global competitiveness. The…
    STAT · 22d agoNegative↗ source
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FDA nominee Heidi Overton’s confirmation won’t be voted on before the midterm elections
The Senate health committee is set to vote on three HHS leadership nominees on Wednesday, but the nomination for FDA commissioner Heidi Overton is not among them. Overton’s confirmation has been p…
STAT · 21d agoNeutral↗ source
  • Sociologist finds vaccine-hesitant parents make logical choices, not anti-science
    Jennifer Reich, a sociologist at the University of Colorado, has spent about twenty years interviewing families who choose not to vaccinate their children. Reich, who herself follows the CDC sched…
    STAT · 22d agoNeutral↗ source
  • SNAP cuts risk increasing child separations, advocates warn
    The latest round of SNAP reductions, the biggest in the program’s history, has already left roughly 1.5 million children without food assistance. Studies cited by the authors suggest that losing t…
    STAT · 22d agoNegative↗ source
  • STAT+: PhRMA taps Eric Cantor as new CEO
    Eric Cantor, a former GOP House majority leader, is taking the helm of PhRMA at a challenging time for the industry.
    STAT · 21d ago↗ source
  • UniQure tumbles with latest data for Huntington’s gene therapy
    Analysts guessed that investors wanted to see stronger durability results at a four-year check-in of the key trial supporting a potential approval of "AMT-130."
    BioPharma Dive · 21d ago↗ source
  • Merck pulls Recarbrio antibiotic from U.S. market, raising concerns over superbug resistance
    Merck announced it has stopped supplying Recarbrio in the United States earlier this month. Recarbrio, a three‑drug combination injection approved seven years ago, is used for severe infections su…
    STAT · 22d agoNegative↗ source
  • Kodiak Sciences' Phase 3 eye drug data beats Regeneron’s Eylea, shares double
    Kodiak Sciences reported that its two experimental treatments for macular degeneration met the primary endpoints in a Phase 3 trial that directly compared them with Regeneron’s Eylea. The data show…
    BioPharma Dive · 22d agoPositive readoutPositive↗ source
  • Merck, Daiichi end plans to seek speedy approval of lung cancer ADC
    The FDA indicated that the data generated so far wouldn’t support an accelerated clearance of “I-DXd,” a setback that erases an edge Merck and Daiichi had over multiple fast-moving competitors.
    BioPharma Dive · 22d agoApprovalPositive↗ source
  • Novo Nordisk rebrands GLP-1 therapy Wegovy as weight-loss product, positioning it as lifestyle drug
    GLP-1 drugs have transformed the lives of millions and were originally promoted as medicines for obesity, a medical condition. Recent advertising campaigns are now presenting these drugs as genera…
    STAT · 23d agoNeutral↗ source
  • Adicet's off-the-shelf CAR-T shows 50% kidney response in early lupus trial
    An early-stage study of Adicet Bio's off-the-shelf gamma-delta CAR-T cell therapy reported encouraging results in patients with lupus nephritis. After a year of follow-up, half of the evaluable pa…
    BioPharma Dive · 22d agoPositive readoutPositive↗ source
  • Rising health insurance premiums and a private equity hospital chain's shift to nonprofit highlight bleak outlook for US healthcare costs
    Bob Herman's latest Health Care Inc. newsletter warns that employer-sponsored health insurance is becoming increasingly unaffordable, with premiums climbing sharply. The piece cites a series called…
    STAT · 22d agoNegative↗ source
  • AbbVie’s once-daily Parkinson’s pill receives FDA approval
    AbbVie announced that the U.S. Food and Drug Administration has granted approval for its once‑daily oral therapy for Parkinson’s disease. The decision allows the product to be marketed in the Unite…
    STAT · 22d agoApprovalPositive↗ source
  • GLP-1 drugs shift from obesity treatment to lifestyle products, prompting setbacks for Merck and Daiichi
    The column notes that GLP-1 medicines, originally marketed to treat obesity as a medical condition, are now being promoted more as general lifestyle enhancers for appearance and wellbeing. Novo No…
    STAT · 22d agoNegative↗ source
  • AI tools that aid vaccine design could also accelerate creation of bioweapons, warns former White House Covid adviser
    Ashish K. Jha, a former White House Covid‑19 response coordinator and senior fellow at Harvard Kennedy School, cautions that artificial intelligence is lowering the barriers that kept biological we…
    STAT · 23d agoNegative↗ source
  • FDA proposes new BsUFA IV commitment letter to streamline biosimilar reviews
    The U.S. Food and Drug Administration released a draft commitment letter for the Biosimilar User Fee Act (BsUFA IV) program, highlighting several departures from the existing biosimilar review fram…
    raps · 23d agoRegulatoryNeutral↗ source
  • FDA CDER chief says expanding generic GLP-1 drugs is top priority to cut American costs
    Michael Davis, director of the FDA's Center for Drug Evaluation and Research, highlighted that increasing the supply of generic GLP-1 medicines is a key focus for the agency. He noted that broader…
    raps · 23d agoRegulatoryNeutral↗ source
  • Trump administration pulls nearly $1 billion from HHS programs for immigrants and diversity
    The White House announced a reversal of almost $1 billion in spending that Congress had previously approved for the Department of Health and Human Services. The reduction was made late on Friday ni…
    STAT · 22d agoRegulatoryNegative↗ source
  • Operational talent, not just science, will drive next biopharma breakthroughs
    The piece points out that while breakthrough science, founders and venture funding are typical markers of progress, the real test is moving a promising therapy through GMP production, quality syste…
    BioPharma Dive · 23d agoNeutral↗ source
  • FDA offers guidance for smoother BLA submissions and outlines biosimilar review changes
    Submitting a biologics license application requires early interaction with the FDA's Office of Therapeutic Products, careful preparation to avoid technical and administrative mistakes, and keeping…
    raps · 23d agoRegulatoryNeutral↗ source
  • FDA advises early engagement and error prevention for BLA submissions, says CBER expert
    A CBER specialist shared practical guidance for companies preparing biologics license applications. The expert stressed that early interaction with the FDA’s Office of Therapeutic Products can str…
    raps · 23d agoRegulatoryNeutral↗ source
  • Study finds toxic metal exposure persists months after Maui wildfires
    University of Hawai‘i researchers examined urine samples from about 1,400 adults as part of the Maui Wildfire Exposure Study, one of the nation’s largest investigations of post‑fire health effects.…
    STAT · 22d agoNegative↗ source
  • Azurity urges simpler medicines for children to reduce daily burdens on families
    Azurity Pharmaceuticals published a sponsored article that looks at how chronic medicines can shape a child's daily routine. The piece points out that while clinical trials test drugs under strict…
    BioPharma Dive · 23d agoPositive↗ source
  • Indian government approves monitoring plan for adverse events in organ and tissue transplantation products
    The Indian government has given formal approval to a new program that will track adverse events linked to medicines and biologics used in organ and tissue transplantation. The initiative is design…
    raps · 23d agoRegulatoryNeutral↗ source