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...
The European Medicines Agency says that a new confidentiality commitment will allow FDA to share confidential commercial information including trade s...
Hyman, Phelps & McNamara asks FDA to add OTC denture repair kits to the list of oral care products exempted from 510(k) premarket notification require...
FDA issues a guidance with recommendations for sponsors of investigational oncology drugs used in companion animals.
FDA issues an internationally harmonized guidance on the nature and types of data that can be useful in determining a toxicological acute reference do...