FDA accepts for priority review a Vertex Pharmaceuticals NDA for tezacaftor/ivacaftor combination use in certain people with cystic fibrosis ages 12 a...
Federal Register notice: FDA seeks comments on an information collection entitled Electronic Submission Process for Voluntary Allegations to the Cente...
FDA grants Epygenix Therapeutics an Orphan Drug Designation for EPX-300 for treating patients with Dravet Syndrome, a lifelong form of epilepsy.
FDA grants Perrigo final approval for its over-the-counter equivalent of AstraZenecas Nexium 24-hour (esomeprazole magnesium) capsules, indicated for ...
FDA approves Adamas Pharmaceuticals Gocovri, the only approved drug indicated to treat dyskinesia in Parkinsons patients receiving levodopa-based ther...
Federal Register notice: FDA seeks comments on an information collection related to Additional Criteria and Procedures for Classifying Over-the-Counte...
Federal Register notice: FDA announces a 9/28 Peripheral and Central Nervous System Drugs Advisory Committee meeting to review a PTC Therapeutics NDA ...
The European Medicines Agency says that a new confidentiality commitment will allow FDA to share confidential commercial information including trade s...