EC allows Amgen to market XGEVA in EU
The marketing authorization was granted on the basis of the results of three Phase 3 trials evaluating XGEVA versus zoledronic acid at delaying SREs. The results of the
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).