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

EU Accelerated Assessment Tracker

Executive Summary

GSK secured accelerated assessment for dostarlimab at the European Medicines Agency but there was no such good news for Merck/AstraZeneca's selumetinib. MYR Pharmaceuticals' bulevirtide has reverted to standard review timelines.

You may also be interested in...



EMA Considers Fast-Tracking Rhythm’s Insatiable Hunger & Obesity Disorders Drug

Setmelanotide, which is being developed to treat insatiable hunger and early-onset severe obesity in people with rare genetic disorders, was also recently submitted to the US regulator for approval.

AstraZeneca/MSD’s Koselugo Among 14 New Hopefuls At EMA

New drugs from Eli Lilly, Pfizer, Janssen, GSK, Arvelle, BioCryst, Diurnal and Myovant are also among the latest products the European Medicines Agency is evaluating for potential pan-EU approval.

Ide-Cel & Enhertu Sponsors Keep Fingers Crossed For EMA Fast-Track

Companies are due to learn this week whether the European Medicines Agency will fast-track its review of their soon-to-be-filed EU marketing applications.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS142026

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