Top Regulatory News Stories – Week Ending February 2, 2018
This week saw a rejection by the FDA for Aradigm, a clinical hold for Bellicum, and a black box warning for Intercept. In addition, the FDA granted a Breakthrough Therapy designation along with a Fast Track designation. Here are the top regulatory stories for the week: The FDA has rejected Aradigm’s inhaled antibiotic Linhaliq[…]