FDA Review Extension

U.S. FDA Extends Review By Three Months For Provention Bio's Type 1 Diabetes Candidate

The U.S. Food and Drug Administration (FDA) has extended its review period by three months for Provention Bio’s (NASDAQ: PRVB) Biologics License Application (BLA) for teplizumab in patients with type 1 diabetes. The regulatory agency has set a new target action goal date of November 17, 2022.

Amylyx Pharmaceuticals Shares Shoot Up As FDA Extends Review Of NDA For Neurodegenerative Disease Candidate

The U.S. Food and Drug Administration (FDA) has extended the review of New Drug Application (NDA) by three months, submitted by Amylyx Pharmaceuticals (NASDAQ: AMLX) for its lead drug candidate AMX0035 with regard to the treatment of patients with amyotrophic lateral sclerosis (ALS).