During the first half of 2019 FDA approved thirteen new investigational drugs for market distribution. The FDA took action on fourteen investigational drugs in July. There were three new approvals in line with the approval pace of the first half. Two drugs received new Priority Designations from the FDA and the agency accepted four new NDAs and three new BLAs. On the other hand, there were setbacks for Intra-Cellular Therapies and Nektar.
July 2019 Approvals
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