Top Regulatory News Stories – Week Ending December 14, 2018

Novartis’ Sandoz unit and Pear Therapeutics announced Monday that the FDA cleared their prescription-only mobile medical app, reSET-O, marking the first FDA-cleared prescription digital therapeutic for patients with opioid use disorder. Stealth BioTherapeutics announced that the FDA has granted Fast Track designation for its lead investigational candidate, elamipretide, for the treatment of dry age-related[…]