The US FDA has approved supplements for 17 drugs, as well as four new molecular entities and novel biologics, under the Real-Time Oncology Review pilot since the program launched in February 2018.
A Rundown Of Real-Time Oncology Review Approvals And Pending Applications
Seattle Genetics holds the award for fastest supplemental approval (11 days) and fastest new molecular entity approval (119 days) under the US FDA's RTOR program, according to the Pink Sheet's Performance Tracker.