Edition:
India

GBT Says U.S. Food And Drug Administration Accepts New Drug Application And Priority Review For Voxelotor For The Treatment Of Sickle Cell Disease


Thursday, 5 Sep 2019 

Sept 5 (Reuters) - Global Blood Therapeutics Inc ::GBT ANNOUNCES U.S. FOOD AND DRUG ADMINISTRATION ACCEPTANCE OF NEW DRUG APPLICATION AND PRIORITY REVIEW FOR VOXELOTOR FOR THE TREATMENT OF SICKLE CELL DISEASE.GLOBAL BLOOD THERAPEUTICS - FDA GRANTED PRIORITY REVIEW FOR NDA FOR VOXELOTOR & ASSIGNED PDUFA TARGET ACTION DATE OF FEBRUARY 26, 2020.GLOBAL BLOOD THERAPEUTICS-FDA ALSO INDICATED THAT IT IS NOT CURRENTLY PLANNING TO HOLD ADVISORY COMMITTEE MEETING TO DISCUSS APPLICATION FOR VOXELOTOR.