Acadia Pharmaceuticals files an NDA for trofinetide for treating Rett syndrome in adults and pediatric patients two years of age and older.
A group of bipartisan lawmakers write FDA asking that it do more to help get therapies approved for treating amyotrophic lateral sclerosis (Lou Gehrig...
Pacific Research Institute president Sally Pipes says FDAs foot dragging in recommending updated Covid-19 vaccines last month and in approving the rel...
Senator Richard Burr (R-NC) introduces a "watered-down" and less controversial FDA user fee reauthorization bill that is intended to address Republica...
FDA approves a Pfizer supplemental NDA for Xalkori (crizotinib) for adult and pediatric patients with unresectable, recurrent, or refractory inflammat...
A federal court has permanently enjoined a Colchester, VT, compounding pharmacy from distributing drugs unless they are manufactured in compliance wit...
FDA clears an Eko 510(k) for its Eko Murmur Analysis Software for use in its smart stethoscope for detecting and characterizing murmurs.
An FDA safety communication advises that testing for monkeypox virus should use swab samples taken directly from a lesion to avoid false test results.