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.
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FDA’s oncology review team likes to do things its own way – and at its own hyper fast pace.
The agency’s quickest approvals include two in 2020 – Gilead’s Veklury and Seattle Genetics’ Tukysa – but two 1990s AIDS drugs are at the top of the list.
With approval of AbbVie Inc./Genentech Inc.'s Venclexta as seventh under RTOR pilot, a roughly two-month median review time under the program could be taking shape.