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

US FDA’s New Drug Median Review Time Held Steady At Eight Months In 2021

Executive Summary

The median review time for novel agents at CDER hasn’t changed in five years. Our infographic offers a look at the tortoises and hares (all of them winners because they got approved).

You may also be interested in...



Keeping Track: Orphan Drugs Aplenty At US FDA, From Pyrukynd Approval To Adagrasib Standard Review

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

Keeping Track: Lilly’s Mounjaro Enters Diabetes Market; Biogen/Eisai Lecanemab Leads Neuroscience News

CDER turned in its 13th novel approval of 2022 on Friday the 13th, and other drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Biohaven’s ‘EpiPen For Migraine’ Intranasal Candidate Rounds Out Prospective Pfizer Portfolio

Real-world evidence – and maybe even an opioid-sparing claim – will be part of Pfizer’s efforts to grow the CGRP space if its $11.6bn bid for Biohaven’s migraine assets goes through. Nurtec ODT (rimegepant) is the star, but pending fast-acting zavegepant could play a valuable supporting role.

Topics

UsernamePublicRestriction

Register

PS145567

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