Top Regulatory News Stories – Week Ending August 2, 2019

Celgene received FDA approval for Otezla to treat oral ulcers associated with Behçet’s Disease. https://www.pharmaceutical-business-review.com/news/celgene-otezla-behcets-disease/ Apic Bio, Inc. announced that the FDA has granted orphan drug designation to APB-102, a gene therapy soon to be in clinical development for the treatment of genetic SOD1 amyotrophic lateral sclerosis (ALS).  http://www.firstwordpharma.com/node/1654288#axzz5uQCOiPcE Biohaven Pharmaceuticals reported that the FDA[…]