Scrip 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

Rocket Pharmaceuticals Inc.

http://www.rocketpharma.com/

Latest From Rocket Pharmaceuticals Inc.

EU Fast-Track Requests For Mozafancogene Autotemcel & Vorasidenib Signal Imminent Filings

The European Medicines Agency is this week deciding whether its reviews of planned marketing applications from Rocket Pharmaceuticals and Servier merit accelerated assessment status.

Europe Review Pathway

Breakthrough Bounceback Looks Unlikely At US FDA’s CDER, But CBER Is Riding Wave Of RMATs

Only two breakthrough-designated novel agents remain on the US FDA drugs center’s 2023 user fee calendar, while CBER stacks up on vaccines and gene therapies under both BTD and RMAT programs.

Review Pathway Approvals

US FDA Struggling With Long-Term Follow-Up Requirements For Gene Therapies

OTP Director Nicole Verdun acknowledged the agency may need help to determine how to ensure 15 years of patient follow-up is completed despite physician retirements, company closures and other issues that could impact the post-market commitments for gene therapies.

Gene Therapy Post Market Regulation & Studies

Keeping Track: Regeneron’s Bispecific Bid, More Regenerative Medicine BLAs, And Vadadustat Returns

Highlights of recent submissions for approval from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Gene Therapy
See All

Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Biotechnology
    • Gene Therapy, Cell Therapy
  • Other Names / Subsidiaries
    • Inotek Pharmaceuticals
    • Renovacor Inc.
UsernamePublicRestriction

Register