US FDA's Real-Time Oncology Review Times Coming Into Focus
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.
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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.
Scientific Wave Pushes CBER Into Brighter Light
What are US regulators doing to prepare for adequate review of the upcoming wave of gene therapy applications, and what other actions could CBER take to ensure it is able to facilitate the expected onslaught of breakthroughs in this field? Consultant Nancy Bradish Myers weighs in.
Keeping Track: Aimmune’s Peanut Allergen Approved; Novartis’ Inclisiran, Pfizer/Lilly’s Tanezumab, Bayer’s Nifurtimox Submitted
Highlights of the latest drug development news from our US FDA Performance Tracker.