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

Speedy Approval Of Gilead’s Veklury Sets Stage For Pediatric Expansion, Dosing Refinement

Executive Summary

US FDA looks to post-marketing studies to address elements of the NDA that were not central to its initial swift approval as the first COVID-19 therapy, including pediatric use and the interaction of hepatotoxicity and dose duration.

You may also be interested in...



Pandemic Perspectives: US FDA ACTT’s On Its Faith In Randomized Trials With Veklury Approval Despite WHO Study

US FDA has not deviated from its bedrock trust in the value of ‘statistically reliable’ endpoints amidst the COVID-19 pandemic, the Pink Sheet’s Drug Review Profile of Gilead’s Veklury shows.

Keeping Track: Chiesi Breathes Easier With Bronchitol Approval; Submissions Aplenty From GSK, Pfizer, AZ, AbbVie

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

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

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

Topics

Related Companies

UsernamePublicRestriction

Register

PS143173

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