[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Considerations for Long-Term Clinical Neurodevelopmental Sa...[ Price : $8.95]
FDA releases a guidance entitled Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA. `[ Price : $8.95]
Gilead Sciences withdraws the accelerated approval for a Trodelvy (sacituzumab govitecan-hziy) indication for treating adult patie...[ Price : $8.95]
FDA approves an Avadel Pharmaceuticals supplemental NDA for Lumryz (sodium oxybate) for treating cataplexy or excessive daytime sl...[ Price : $8.95]
Boston Scientific recalls (Class 1) its Obsidio Conformable Embolic device to update the use instructions due to a concern about r...[ Price : $8.95]
FDA publishes a guidance outlining a framework for considering the types of long-term neurodevelopmental safety studies that could...[ Price : $8.95]
FDA says it is continuing to review the sNDA submitted by Intercept Pharmaceuticals for its Ocaliva following an advisory committe...[ Price : $8.95]
FDA approves an AbbVie NDA for Vyalev (foscarbidopa and foslevodopa), a subcutaneous 24-hour infusion of levodopa-based therapy fo...