unmet
FDA Launches New Priority Review Voucher Program Aligned with National Priorities
FDA; priority review voucher; CNPV; biopharma; drug approval; national priorities; accelerated review; unmet public health needs
FDA Advisory Committee Supports Stealth BioTherapeutics’ Elamipretide for Barth Syndrome Despite Data Concerns
Stealth BioTherapeutics, elamipretide, Barth syndrome, FDA advisory committee, ultra-rare disease, unmet medical need