Tzield approval another sign Makary era over

The accelerated approval of an sBLA for Sanofi’s Tzield, announced Friday, is another sign that FDA’s leadership is moving past the Makary era and isn’t looking in the rearview mirror.

Tzield teplizumab took a wild ride through former Commissioner Marty Makary’s FDA, experiencing an unexpected boost and an equally surprising delay, before gliding to approval under the agency’s new acting leaders. ...