FDA
Shares of Prometic Life Sciences Inc. jumped this morning after securing the U.S. Food and Drug Administration’s Rare Pediatric Disease Designation.
The U.S. Food and Drug Administration (FDA) issued new draft guidance for preclinical trials in Alzheimer’s.
Asthma patients may soon have a new treatment option.
Sorrento Therapeutics, Inc. nabbed regulatory approval for ZTlido, a non-opioid pain treatment in the form of a super-sticky patch.
Shares of Portola Pharmaceuticals are falling after the company announced a delay of several months for possible regulatory approval of its Factor Xa-inhibitor antidote, AndexXa.
The U.S. Food and Drug Administration stunned the company with a Refusal to File letter regarding its New Drug Application (NDA) for multiple sclerosis treatment ozanimod.
Beijing-based Yisheng Biopharma Co. is celebrating this morning after its lead immunology treatment snagged a second Orphan Drug Designation from the U.S. Food and Drug Administration.
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) announced a string of approvals, as well as a couple rejections.
The U.S. Food and Drug Administration (FDA) has granted Shire’s Biologics License Application (BLA) for lanadelumab (SHP643) priority review.
Novartis is eying a possible 2019 launch for RTH258 (brolucizumab), an ophthalmology drug for the treatment of neovascular age-related macular degeneration.
PRESS RELEASES