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.

Menu

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
My View
Tags:
Drug Approval Standards Drug Review Regulation

Resubmission After Withdrawal: US FDA’s Mavenclad Approval Acknowledges Long Regulatory History

  • Analysis

Executive Summary

EMD Serono’s multiple sclerosis drug joins small cadre of products that survived a refuse to file letter and NDA withdrawal; chart details recent RTFs and application withdrawals.

You may also be interested in...



US FDA Filing Mistake For Fintepla Dents Zogenix

Zogenix seems only to have itself to blame for an unexpected refusal to file letter from the US agency for its novel treatment for Dravet syndrome that sent its shares tumbling by 31% on NASDAQ in after-hours trading.

Keeping Track: Approvals For Mayzent, Mavenclad, Duaklir, Jatenzo And Cimzia

The latest drug development news and highlights from our US FDA Performance Tracker.

Keeping Track Of Non-Oncology Review and Approval News: Erectile Dysfunction, Parkinson's, Cholesterol

The latest non-oncology drug development news and highlights from our US FDA Performance Tracker.

Table

View full table

Topics

Related Companies

Tags:
Drug Approval Standards Drug Review Regulation
Latest Headlines

US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios

FTC Early Findings In PBM Investigation Coming By Mid-Summer, Chair Kahn Says

New EU Filings

WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency

See All
UsernamePublicRestriction

Register

PS125240

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

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