Keeping Track: Orladeyo, Danyelza, Imcivree Bring CDER 2020 Novel Approval Count Even With Full-Year 2019

With the approval of BioCryst Pharmaceuticals, Inc.’s Orladeyo (berotralstat) on 3 December 2020, the US FDA’s Center for Drug Evaluation and Research matched the full-year novel approval count from 2019, 48 novel agents, with most of a month remaining in 2020.

Orladeyo was one of four new molecular entities and novel biologics approved in the past two weeks, after Y-mAbs Therapeutics Inc.’s Danyelza (naxitamab-gqgk) and Rhythm Pharmaceuticals, Inc