Teva files lawsuit against FDA
Teva argued that the FDA’s denial of Teva’s Citizen’s petition, seeking the relisting of US patent and restoration of Teva’s 180-day exclusivity for its pending abbreviated new drug
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).