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

Spark's Early Christmas Present: US FDA Approves Luxturna For Vision Loss

Executive Summary

Review and approval of first directly administered gene therapy targeting a disease caused by genetic mutations embodies 'spirit' of agency's forthcoming series of guidance documents on gene therapies, FDA Commissioner Gottlieb says; documents are likely to encourage development of the kind of novel and clinically meaningful endpoint that Spark used in its clinical program.

Advertisement

Related Content

NIH Ends Gene Therapy Trial Reporting Requirements In Reg Streamlining Move
Gene Therapy Guidance From US FDA Likely Needs Updating Sooner Rather Than Later
NIH Ends Gene Therapy Trial Reporting Requirements In Reg Streamlining Move
The Luxturna Model: Spark’s Approach To Retinal Disease Endpoint Embraced In Gene Therapy Guidance
Orphan Incentives: Voucher Price Drop Gives Some Sponsors 'Pause'
Gene Therapy Guidances Will Focus On Specific Diseases, Gottlieb Says
Keeping Track: Another Gene Therapy Approval, Several Priority Review Designations, And Many Resubmissions
Spark's Gene Therapy Luxturna Sails Through US FDA Panel
Spark's Vision Loss Gene Therapy Raises US FDA Questions About Novel Endpoint
Novartis CAR-T Therapy's Swift Approval Aided By REMS And New US FDA Review Model

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS122179

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