FDA is a ticker tracked in our intelligence system with 5 linked articles.
STAT publishes a caregiver's firsthand account of one family's journey through the clinical trial for daraxonrasib (Rasonque), the newly FDA-approved pancreatic cancer drug — humanizing color, not decision-grade intelligence.
A STAT+ Health Tech newsletter teaser noting the FDA has finalized its guidance on prescription drug use-related software (welcomed by pharma) and that telehealth players are pushing GLP-1s for addiction.
STAT+ reports that telehealth platforms are prescribing GLP-1s off-label for addiction ahead of any FDA approval for that indication, with experts warning of fragmented care and unknown patient risks.
GSK won FDA approval for its hepatitis B drug, which reportedly delivers functional cures to far more patients than previous treatment approaches.
Bipartisan lawmakers are pressing the FDA to close a regulatory loophole that allows gray-market importation of knockoff retatrutide, Eli Lilly's investigational triple-agonist obesity drug.
Following its FDA green light, Revolution Medicines' pancreatic cancer drug Rasonque has now received a positive approval recommendation from European regulators, securing a second major-market regulatory win.
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