FDA grants Sage Therapeutics an orphan drug designation for SAGE-718 and its use in treating Huntingtons disease.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Fresenius Kabis Omegaven (fish oil triglyceride...
Three trade groups raise concerns and make suggestions for the FDA Information Technology Strategy.
The Advanced Medical Technology Association urges FDA to proceed with stakeholder recommendations to develop a central patient-reported outcomes tool ...
FDA issues a warning on the use of 26 over-the-counter eye drop products due to the potential risk of eye infections that could result in partial visi...
Sarepta Therapeutics says it will file a supplemental BLA for Elevidys (delandistrogene moxeparvovec-rokl) to expand the therapys use in all patients ...
GSK says a Phase 3 trial evaluating its Jemperli (dostarlimab) in adult patients with primary advanced or recurrent endometrial cancer met its primary...
Novartis says it will seek FDA accelerated approval for atrasentan and its use in treating patients with IgA nephropathy.
