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

Gilead’s Veklury Approval Shows US FDA’s Existing Regulatory Tools Are Up To The COVID-19 Challenge

Executive Summary

The FDA emphasized the rigor of its review of the first COVID-19 therapy, which used few expedited pathways on its way to approval after a two-and-a-half-month review. Post-marketing studies will address remaining concerns about dosing and special populations.

You may also be interested in...



Thinking Post-COVID: How Will US FDA Transition Drug, Vaccine EUAs To Full Approvals?

Sponsors seek clarity about the transition process, which could last a year or longer.

Moderna’s COVID Vaccine Sheds Negative Comparison On Myocarditis With BLA Approval

Unlike the current EUA fact sheet, Spikevax’s approved labeling does not state that the vaccine may pose an increased risk of myocarditis ‘relative to other authorized or approved mRNA COVID-19 vaccines.’ Approval brings Moderna a priority review voucher, as did Comirnaty’s approval for BLA sponsor BioNTech.

Keeping Track: Immunocore Wins Nod For First T-Cell Receptor Therapeutic; Veklury And Nucala Expand Settings Of Use; Merck & Co. Strikes Out In Chronic Cough

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

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS143164

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