A complete response letter (CRL) for Acer Therapeutics Inc.'s vascular Ehlers-Danlos syndrome candidate Edsivo (celiprolol) capped off a relatively difficult first half of 2019 for novel drugs and biologics under review at the US Food and Drug Administration.
The Center for Drug Evaluation and Research approved only 13 novel products in the first six months of the year, while handing out at least seven CRLs for such products