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

EMA Doubles Number Of EU Early Access Approval Recommendations

13 CHMP Positive Opinions Were For Conditional Marketing Authorization

Executive Summary

The EU’s special provisions for speeding new products towards approval proved more popular than ever with drug sponsors last year.

You may also be interested in...



Elzonris: A Case Study In Divergent Regulatory Decisions

Stemline Therapeutics’ Elzonris was approved for a rare cancer in Europe in January, following a long and arduous two-year journey through the EU regulatory process that included an initial rejection and a subsequent re-examination by the EMA. Its fortunes were very different in the US, where the review took just six months from filing to approval.

Turalio: Why The EU Said No To The US-Approved Drug

Not everyone reviewing Daiichi Sankyo’s EU marketing application for Turalio agreed that the potential tenosynovial giant cell tumor treatment shouldn't be approved.

EMA Dashes Sobi’s EU Gamifant Marketing Hopes

The European Medicine Agency has stood firm on its decision to recommend against pan-EU marketing approval for Gamifant.

Topics

Related Companies

UsernamePublicRestriction

Register

PS144497

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