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1,883 stories matching this filter · ← front page

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  • 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
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  • 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 · 23d agoRegulatoryNegative↗ 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
  • 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
  • Trump administration seeks Supreme Court stay on gender-affirming care restrictions in federal prisons
    The Trump administration filed an emergency petition with the Supreme Court asking it to pause a district judge’s order that requires continued provision of gender-affirming medical treatments to i…
    STAT · 23d agoRegulatoryNeutral↗ source
  • Researchers identify previously unseen structure in the human heart
    An author of an opinion piece reports that a close visual inspection of the heart revealed a previously unrecognized anatomical structure. The discovery was made without new imaging technology, sim…
    STAT · 23d agoPositive↗ source
  • Former CDC investigator warns that gaps in public-health readiness leave the U.S. vulnerable to future biothreats
    Daniel Jernigan, a former CDC scientist who helped investigate the 2001 anthrax mailings, reflects on the lessons learned two and a half decades later. The anthrax letters, sent from New Jersey to…
    STAT · 25d agoNeutral↗ source
  • Trump administration cancels nearly $1 billion of congressional spending, targeting refugee and immigrant services
    The White House announced on Friday that it is using a rarely invoked authority to rescind almost $1 billion in funding that Congress had approved earlier. The cuts focus mainly on Health and Huma…
    STAT · 25d agoNegative↗ source
  • FDA approves Lilly's once-weekly basal insulin Onswik for adults with type 2 diabetes
    The U.S. Food and Drug Administration has granted approval to Eli Lilly’s Onswik, a basal insulin designed for once-weekly injection in adults with type 2 diabetes. The new formulation offers patie…
    STAT · 26d agoApprovalPositive↗ source
  • UN-backed agency secures sub-licensing deals for generic Roche flu drug across 129 low- and middle-income countries
    An agency supported by the United Nations has finalized sub-licensing contracts with eleven drug manufacturers to create generic versions of Roche’s influenza medication Xofluza. The agreements al…
    STAT · 26d agoDealPositive↗ source
  • Five candidates vie for WHO director‑general role as agency faces US funding pullback and tighter global health budgets
    At least five candidates are in the running to become the next director‑general of the World Health Organization, a race analysts say could be the most consequential in the agency's recent history.…
    STAT · 26d agoNeutral↗ source
  • Veteran Russell Shilling leads new federal autism research initiative
    Russell Shilling, a Navy veteran and father of two sons with autism, has been appointed to lead the Advanced Research Projects Agency for Health's new autism project. The initiative is described a…
    STAT · 26d agoPositive↗ source
  • Tobacco companies submitted 175,000 largely duplicate comments to block FDA menthol cigarette ban
    Researchers at Rutgers University analyzed the public comment period for the FDA’s 2022 proposal to ban menthol cigarettes and found that out of 175,000 submissions, 97% were form letters and only…
    STAT · 26d agoRegulatoryNegative↗ source
  • Experts say measles death counts are muddled by 'with' vs 'of' debate
    Public health scientists note that Pennsylvania reported two measles‑related deaths in August, but the county coroner described one infant as having died "with" measles rather than "from" the disea…
    STAT · 26d agoNeutral↗ source
  • Rakuten Medical appoints Hassan Danesi as chief medical officer, coming from Coherus Biosciences
    Rakuten Medical announced that Hassan Danesi will join the company as its new chief medical officer. The appointment was disclosed in a recent industry column. Danesi previously served as vice pre…
    STAT · 26d agoNeutral↗ source
  • Opinion: RFK Jr.’s use of the National Center for Health Statistics will add confusion to measles deaths count
    “A discrepancy between how federal and state public health officials determine measles deaths will only increase public confusion,” write Denys T. Lau and Jennifer D. Schoendorf.
    STAT · 26d agoNeutral↗ source
  • Federal judge overturns key disability protection law
    A federal judge has reversed a longstanding disability protection ruling, reducing the legal safeguards that favored community-based living over institutional care. The Justice Department had anno…
    STAT · 26d agoRegulatoryNegative↗ source
  • Opinion: FDA commissioner nominee Heidi Overton is ignoring the science on abortion drug
    “With this latest appointment, mifepristone has a new boss but an old problem,” writes Julie F. Kay, founder and CEO of Reproductive Futures.
    STAT · 26d ago↗ source
  • STAT+: Pharmalittle: We’re reading about a reticent FDA commish nominee, a Novo deal, and more
    President Trump’s nominee to lead the FDA was grilled by senators on hot button topics like China, vaccines, and abortion access
    STAT · 26d ago↗ source
  • Heidi Overton, a New Mexico-born physician, nominated as FDA commissioner
    Heidi Overton grew up in Gallup, New Mexico, and as a college freshman expressed a desire to become a doctor and return to her small hometown. Her early ambition was highlighted in a 2007 intervie…
    STAT · 27d agoRegulatoryPositive↗ source
  • FDA nominee Heidi Overton avoids taking positions in Senate hearing on vaccines, China and abortion
    Heidi Overton, President Trump’s pick to lead the Food and Drug Administration, appeared before the Senate health committee for a two hour hearing. Senators focused their questions on China, vaccin…
    STAT · 26d agoRegulatoryNegative↗ source