Orphans Dominate New US FDA Approvals, Thanks To Rethymic, Tavneos, And Livmarli
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
You may also be interested in...
J.P. Morgan Day 4: Preparing For The Year Ahead
Daily notebook from the virtual J.P. Morgan Healthcare Conference: Updates from Galapagos, Ipsen, LG Chem and Hanmi; experts discuss deal and financial outlook at Biotech Showcase, plus the impact of RMAT and the changing landscape for rare diseases.
J.P. Morgan Day 4: Preparing For The Year Ahead
Daily notebook from the virtual J.P. Morgan Healthcare Conference: Updates from Galapagos, Ipsen, LG Chem, Hanmi and Fosun; experts discuss deal and financial outlook at Biotech Showcase, plus the impact of RMAT and the changing landscape for rare diseases.
Enzyvant’s Path From Complete Response Letter To FDA Approval For Rethymic Included CMC Revamp
Two-year journey after CRL did not start with a meeting with US FDA, but rather a ‘pause’ to better understand agency’s perspective, execs say. Firm would later develop a roadmap with FDA to overcome manufacturing issues for the the first tissue-based therapeutic approved by the agency.