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: US FDA's Rejection Of First RMAT BLA Blemishes Otherwise Positive Week Of Non-Oncology News

Executive Summary

The latest non-oncology drug development news and highlights from our US FDA Performance Tracker.

You may also be interested in...



Keeping Track: First COVID Vaccine BLA Kicks Off; Oncology Submissions From Hutchmed, Takeda And Shorla

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

ViiV’s Fostemsavir Loses EU Fast-Track Status

Viiv Healthcare's marketing application for fostemsavir started off being fast-tracked through the review process at the European Medicines Agency in January but is now being reviewed under standard timelines. The product is being developed for the treatment of adults with multidrug resistant HIV-1 infection.

Mallinckrodt StrataGraft Skin Therapy Could Be The First RMAT-Designated Therapy Approved By US FDA

The company presented positive data from a Phase III pivotal trial during the American Burn Association virtual annual meeting.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS141329

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