Gilead Sciences withdraws the accelerated approval for a Trodelvy (sacituzumab govitecan-hziy) indication for treating adult patients with locally adv...
FDA approves an Avadel Pharmaceuticals supplemental NDA for Lumryz (sodium oxybate) for treating cataplexy or excessive daytime sleepiness in patients...
Boston Scientific recalls (Class 1) its Obsidio Conformable Embolic device to update the use instructions due to a concern about risks when using it a...
Federal Register notice: FDA makes available a final guidance requesting the reconsideration of an ANDA decision at the division level.
Staska Pharmaceuticals recalls one lot of ascorbic acid solution for injection (500mg/mL, 50mL vials) due to the presence of glass particulates in som...
FDA publishes a guidance with recommendations for collecting a core set of patient-reported clinical outcomes in cancer clinical trials.
FDA publishes a guidance outlining a framework for considering the types of long-term neurodevelopmental safety studies that could support a determina...
FDA says it is continuing to review the sNDA submitted by Intercept Pharmaceuticals for its Ocaliva following an advisory committee 10-1 vote not to r...
