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

Keeping Track: A Lawsuit-Driven Complete Response Letter, A Refuse To File Letter, And Some Good News

Executive Summary

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

You may also be interested in...



Stealth Elamipretide NDA Tests Frontiers Of US FDA’s Flexibility In Rare Diseases

FDA wants another trial in ultra-orphan Barth syndrome, but could not identify a feasible design – so Stealth submitted the NDA anyways, based on a retrospective natural history control trial

Imaging Drugs Make Jump To Devices In New Decision By FDA

After losing the recent Genus Medical Technologies court case, the US FDA will begin transitioning certain imaging agent drugs to devices.

Keeping Track: US FDA Approves Heron’s Zynrelef In Post-Op Pain; Amgen/AZ Submit Tezepelumab For Severe Asthma

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

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS145291

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