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.  https://www.firstwordpharma.com/node/1610616 Stealth BioTherapeutics announced that the FDA has granted Fast Track designation for its lead investigational candidate, elamipretide, for the treatment of dry age-related[…]