Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

A Rundown Of Real-Time Oncology Review Approvals And Pending Applications

Executive Summary

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.

You may also be interested in...



US FDA’s Three Review Speeds: Standard, Priority – And Oncology

FDA’s oncology review team likes to do things its own way – and at its own hyper fast pace.

US FDA’s Fastest Approvals Concentrate In Oncology, Infectious Disease

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.

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.

Topics

Related Companies

UsernamePublicRestriction

Register

PS142990

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel