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

The US FDA’s Nifty Fifty

Executive Summary

FDA has approved over 50 new molecular entities in a year for the second time – a truly remarkable job amid a global pandemic. But will 2021 be a tougher year?

You may also be interested in...



Is The US FDA At A Tipping Point?

Wall Street is worried that a cluster of recent negative regulatory events means tougher reviews going forward. That concern is probably overdone, but a year into the COVID pandemic is a good time to take stock of how FDA is doing.

2020 Drug Launches, Like Everything, Will Be Remembered For COVID-19

Gilead's Veklury for the treatment of COVID-19 was a clear commercial standout among new drugs in 2020, but cancer drugs like Seagen's Padcev and Tukysa are poised for long-term potential.

US FDA 2020 Novel Approval Count Rises To 53 At CDER, Plus 5 New CBER Biologics

FDA reviewers stuck to established assessment practices during the coronavirus crisis and produced one of the agency’s largest yearly novel approval counts ever.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143522

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