Only four of 14 voting panelists are regular members of the Cellular, Tissues and Gene Therapies Advisory Committee, with scheduling conflicts precluding participation by many others, the FDA said. Three of the temporary members are veterans of prior muscular dystrophy drug reviews.
The US advisory committee that will consider Sarepta Therapeutics, Inc.’s gene therapy SRP-9001 (delandistrogene moxeparvovec) for accelerated approval is composed largely of temporary voting members, three of whom have prior experience with muscular dystrophy drug reviews.
There will be 14 voting members when the Cellular, Tissues and Gene Therapies Advisory Committee (CTGTAC) convenes on 12 May to review
The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.
Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.
Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
