Phase III
Auris Medical has gone down swinging again in attempting to develop a treatment for tinnitus after it announced its Phase III trial failed to meet endpoints.
AbbVie and Neurocrine Biosciences announced that its Phase III ELARIS UF-II trial of elagolix for uterine fibroids met its primary endpoint.
After a hard-fought battle to win the green light for Exondys 51 from the U.S. Food and Drug Administration, Sarepta Therapeutics is planning on seeking approval of a second treatment for Duchenne muscular dystrophy (DMD).
Esperion announced that its bempedoic acid for lowering LDL-C cholesterol had positive results in a Phase III clinical trial.
Dermira plans to shutter the program and move on to more promising compounds.
Vanda Pharmaceuticals announced positive results from its JET8 Phase III clinical trial of Hetlioz for jet lag disorder.
Asthma patients may soon have a new treatment option.
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.
Eli Lilly snagged regulatory approval for expanded use of cancer treatment Verzenio.
PRESS RELEASES