Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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: Immunology Drives US FDA Action, With Approvals For AZ/Amgen’s Tezspire, Argenx’s Vyvgart, And New JAK Uses

Executive Summary

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

You may also be interested in...



High-Stake Meetings With EMA In Store For Sponsors Of EU Filings

The sponsors of six drugs that are nearing the end of the regulatory review cycle in the EU could this week be asked to explain why the European Medicines Agency should recommend approving their products.

First-In-Class Drugs Made Up More Than Half Of US FDA’s Novel Approvals Last Year

CDER hit a high mark with 27 first-in-class approvals in the 50 novel agents cleared in 2021.

How RWE Was Used For Opdivo, Abecma & Orencia Approvals

Bristol Myers Squibb’s use of real-world evidence in US and EU marketing applications for three of its products shows how population bridging, external controls and comparative effectiveness might be employed.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS145421

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