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

Missed Review Deadlines Are Reminder That On-Time Approvals Are A Goal, Not A Guarantee

Executive Summary

After more than a decade of sky-high rates of on-time regulatory action by the US FDA, missed user fee goal dates are back in a pretty big way – and it’s not just JAK inhibitor and COVID-19 delays.

You may also be interested in...



Sanofi/Regeneron’s Esophagitis Data Add To Dupixent’s Winning Streak

The companies announced positive Phase III data for the drug in patients with eosinophilic esophagitis and plan to take the results to regulators in 2022.

Delay Looms For Axsome Therapeutics’ Entry Into Major Depressive Disorder Market With Lead Product

Axsome Therapeutics’ lead candidate, AXS-05, was nearing the US market for major depressive disorder, but the US company is trying to find out more about deficiencies identified by US regulators; the biotech has also reported positive Phase II results in treatment-resistant depression.

Keeping Track: US FDA Clears Opioid Seglentis And Anti-Opioid Zimhi; CRLs For Revance, United; Delay For UCB

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

Topics

Related Companies

UsernamePublicRestriction

Register

PS144970

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