Pink Sheet is part of the Business Intelligence Division 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

Gene Therapies: Accelerated Approval Open For Some, But Not All, Neurodegenerative Disease Treatments

Executive Summary

US FDA’s Gottlieb tells J.P. Morgan that curative gene therapies may be ripe for accelerated approval while those targeting symptoms may require more conventional development programs; forthcoming agency guidance will articulate this divide specific to neurodegenerative diseases, he says.

Advertisement

Related Content

Shutdown Bite Tightens At US FDA, But Gene Therapy To Get 50 More Reviewers
US FDA's New Development Science Office Modeled On Modeling Office
Shutdown Week Three: Sponsors With Upcoming User Fee Dates Should Start Sweating
Gottlieb On Gene Therapies: 'Very Seductive' To Think About Accelerated Approval Pathway

Topics

Advertisement
UsernamePublicRestriction

Register

PS124521

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