FDA releases a guidance entitled Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA. `
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...
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...
FDA approves an AbbVie NDA for Vyalev (foscarbidopa and foslevodopa), a subcutaneous 24-hour infusion of levodopa-based therapy for treating advanced ...
FDA posts a draft guidance entitled Postoperative Nausea and Vomiting: Developing Drugs for Prevention.
