FDA commissioner Robert Califf and chief scientist Namandj Bumpus withdraw Covis Pharmas preterm birth drug Makena and its generics from the market ef...
FDA clears a restor3d 510(k) for the Axiom PSR System for use with the companys Kinos Axiom Total Ankle System.
The Justice Department says two Texas men face up to five years in prison after pleading guilty to selling misbranded drugs over the Internet.
Federal Register notice: FDA announces the availability of a draft guidance entitled Human User Safety (HUS) in New and Abbreviated New Animal Drug Ap...
FDA publishes the last in a series of four guidances on aspects of patient-focused drug development.
The Justice Department charges three former top officials at Magellan Diagnostics over their role in allegedly concealing a device malfunction that pr...
FDA warns Somerset, NJ-based Aspire Pharmaceuticals about multiple violations in its production of dietary supplements and human drugs.
Scorpion Capital says its research into deaths and adverse events associated with Harmony Biosciences narcolepsy drug Wakix indicates FDA should withd...
