Sandoz asks the DC federal court to order FDA to set aside its award of new chemical entity status and exclusivity to Sanofi Genzymes Aubagio and to a...
The Association for Accessible Medicines raises several concerns with an FDA final guidance on controlled correspondence related to generic drug-devic...
FDA clears a Brain Scientific 510(k) for its NeuroCap device, an advanced electroencephalogram electrode array used to obtain rapid EEGs in routine cl...
GlobalData says that positive results from two Jyseleca testicular safety studies could lead to FDA approval for an indication for ulcerative colitis ...
FDA clears an Ultragenyx Pharmaceutical IND for UX053, an investigational mRNA therapy being evaluated for treating Glycogen Storage Disease Type III.
FDA grants Kite accelerated approval for Yescarta (axicabtagene ciloleucel) for treating adult patients with relapsed or refractory follicular lymphom...
FDA tells Soleno Therapeutics that an additional controlled clinical trial will be necessary to support an NDA submission for DCCR (diazoxide choline)...
FDA grants Viatria and Kindeva Drug Delivery tentative approval for budesonide/formoterol fumarate dihydrate, the first generic version of AstraZeneca...