breakthrough therapy designation

Follow-up trials should be underway for accelerated nods: Pazdur

"Substantially” or “fully” enrolled confirmatory trials aren’t a condition of all accelerated cancer approvals, according to the FDA's Richard Pazdur.

Angus Liu Nov 17, 2022 3:36pm

FDA seeks to pull Protagonist breakthrough nod over malignancies

Apr 14, 2022 7:30am