Page 16 - Priority Review News Today

Iloprost had also received Priority Review and Orphan Drug Designations for this indication, and FDA approval in 2004 for the treatment of pulmonary arterial hypertension.

The FDA approved an injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation.

The investigational therapy combines MDMA, a psychoactive drug, with psychological interventions that include psychotherapy, talk therapy and other supportive services.

Seladelpar is an investigational, first-in-class oral, selective peroxisome proliferator-activated receptor delta agonist.

New Prescription Drug User Fee Act date of June 30, 2024 ...

The FDA has accepted Lykos Therapeutics New Drug Application, supported by two decades of research incubated by MAPS, for MDMA-assisted therapy for PTSD....

BOSTON & LONDON, Feb. 09, 2024 -- Centessa Pharmaceuticals plc announced that data from an additional 52-weeks of continuous treatment from the third year of the ongoing Phase 2a study of...

Humacyte's shares surge as FDA grants Priority Review to its BLA for Human Acellular Vessel (HAV) used in urgent arterial repair.

Humacyte, Inc. HUMA shares are trading higher on Friday. The company announced that the U.S. FDA has accepted and granted Priority Review to Humacyte’s…

Strong growth and pipeline momentum with three new medicines approved since the third quarter ...