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
UsernamePublicRestriction

EU Accelerated Assessment Tracker

Executive Summary

Two products that were under fast-track review at the European Medicines Agency have reverted to standard review timelines – Eiger's lonafarnib and GSK's dostarlimab. The Pink Sheet tracker logs these and other developments relating to the agency's accelerated assessment mechanism.

You may also be interested in...



EU Fast-Track Review In Store For Takeda’s Dengue Vaccine

Takeda will soon seek EU approval of its dengue vaccine candidate. The marketing application will be fast-tracked, as will the applications for Regeneron's evinacumab and bluebird bio's eli-cel Lenti-D gene therapy.

EU: BTG Tries Again With Voraxaze After 15 Years

Voraxaze, vosoritide and TransCon hGH are among the latest products that have been submitted to the European Medicines Agency for review for potential pan-EU marketing approval.

Zolgensma First To Be Subject To New German Data Collection Rules

The G-BA has explained in more detail the procedures for mandating post-launch evidence generation under new legislation introduced in 2019.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

MT142578

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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