Six PDUFA dates on FDA’s July calendar

At least six action dates are on FDA’s roster in July, including decisions on priority reviews of Eisai’s Alzheimer’s disease therapy Leqembi and Daiichi’s AML therapy quizartinib.

First up, on July 6, is the PDUFA date for an sBLA seeking conversion of the accelerated approval of Leqembi lecanemab from Eisai Co. Ltd. (Tokyo:4523) and partner  Biogen Inc. (NASDAQ:BIIB) to full approval for patients with mild cognitive impairments or mild dementia due to Alzheimer’s disease. ...