FDA accepts Samsung Bioepis’ BLA for Humira biosimilar
The BLA for SB5 was submitted by Samsung Bioepis in July 2018. The BLA for SB5 was based on data derived from a randomized, double-blind 52-week Phase 3
HAYA Therapeutics has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational therapy, HTX-001, to treat symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).