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 Crunch Time For Two Drugs That Lost Their Fast-Track Status

Executive Summary

Karyopharm and GSK should soon learn whether the European Medicines Agency will recommend EU approval for their respective products, selinexor and dostarlimab.

You may also be interested in...



Dostarlimab, Zynteglo & COVID-19 Combo Drugs In The Spotlight At EMA

The sponsors of seven new drugs are set to find out this week whether the European Medicines Agency’s human medicines committee, the CHMP, will recommend pan-EU approval for their products. CHMP action is also expected regarding two potential combination therapies for COVID-19.

13 New Drugs Pass Muster At The EMA, Dexamethasone Withdrawal Explained

New products from Paion, Arvelle, Incyte and many others have been recommended for approval by the European Medicines Agency. Meanwhile, the agency has explained why the EU marketing authorization application for Dexamethasone Taw, for treating COVID-19 patients, was withdrawn.

Bumpy EU Review Ends Well For Selinexor Filing

Karyopharm says its treatment for patients with refractory multiple myeloma could become its first product to be approved in Europe.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS143665

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