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...
FDA releases the form FDA-483 with three observations from its inspection at the Lupin drug manufacturing facility in Pithampur, Madhya Pradesh, India...
