Keeping Track: US FDA's Rejection Of First RMAT BLA Blemishes Otherwise Positive Week Of Non-Oncology News

First, the bad news: It will be a longer wait before the first product with regenerative medicine advanced therapy (RMAT) designation gets approved, as the US Food and Drug Administration issued a complete response letter (CRL) to Enzyvant Sciences Ltd. for its congenital athymia candidate RVT-802.

The news comes just as the 21st Century Cures Act, which authorized the RMAT pathway, is about to hit its...