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: Terlipressin Falls Short Of US FDA Approval; Novel NDAs From Pfizer And Apellis; New BTDs For Sanofi, BeyondSpring

Executive Summary

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

You may also be interested in...



Keeping Track: Keytruda Adds TNBC Claim; Finerenone, Brincidofovir, HTX-011 Submitted; CRL For Supernus’ ADHD Drug

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

Bluebird’s Eli-Cel Gene Therapy Among Myriad New Drugs Seeking EU Approval

An advanced immunotherapy for recurrent glioblastoma and the first biosimilar version of Lucentis for age-related macular degeneration have also been submitted for review by the European Medicines Agency for potential pan-EU authorization.

Mallinckrodt’s Terlipressin Narrowly Clears US FDA Panel As Need For Liver Treatment Outweighs Safety Worries

Advisory committee votes 8-7 to recommend approval for terlipressin to treat HRS-1 but is critical of Mallinckrodt’s plan to mitigate the risk of respiratory failure.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS142951

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