Atara Biotherapeutics Reports that the Resubmitted Tabelecleucel (Tab-cel®) Biologics License Application Has Been Accepted by the U.S. Food and Drug Administration
Atara Biotherapeutics reported that the FDA accepted the resubmitted Biologics License Application for tabelecleucel. The application was resubmitted by its partner, Pierre Fabre Pharmaceuticals.
Why it matters — The FDA’s acceptance is a regulatory development concerning tabelecleucel, a therapy being developed by Atara and its partner.