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
UsernamePublicRestriction

US FDA’s Median Review Time For Novel Drugs Held Steady In 2020

Executive Summary

Even in the grip of the pandemic, review times for priority drugs were also consistent with the last three years.

You may also be interested in...



Keeping Track: Novel Orphan Drugs Amondys 45, Nulibry Clear US FDA; First-Line NSCLC Claim For Libtayo

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Keeping Track: Novartis Entresto Wins Expanded Heart Failure Claim; Padcev, Vicineum Seek Bladder Cancer Approvals

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Complexity Has Benefits: Data Show Biologics, Targeted Agents Have Better Approval Prospects

Biologics have 9.1% likelihood of making it through the clinic to approval, compared to 5.7% for new molecular entities, according to an analysis of 10 years of Biomedtracker drug development data by BIO, Informa Pharma Intelligence and QLS.

Topics

UsernamePublicRestriction

Register

ID1135947

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