Sen. Jim Banks (R-IN) urges FDA to step up inspections of pharmaceutical manufacturing facilities abroad, citing persistent quality lapses and lagging...
Attorneys from Mintz warn that FDAs recent safety communication on acetaminophen and autism may signal a departure from long-standing procedures for d...
FDA accepts for priority review a Johnson & Johnson supplemental NDA for Akeega (niraparib and abiraterone acetate dual-action tablet) plus prednisone...
Novartis reports that a Phase 3 trial of its oral complement inhibitor Fabhalta (iptacopan) showed the therapy slowed kidney function declines in cert...
Two academic researchers urge FDA to require a Drug Facts box in direct-to-consumer ads so consumers can understand a drugs benefits and risks.
Johnson & Johnson says an independent data monitoring committee recommended unblinding the MajesTEC-3 study of Tecvayli and Darzalex Faspro following ...
Hyman, Phelps & McNamara principal medical device regulation expert Adrienne Lenz says FDA is preparing for a future where artificial intelligence and...
FDA urges the Supreme Court to reject Vanda Pharmaceuticals petition challenging the agencys decision to deny fast-track status for its experimental d...
