FDA extends review for second NDA of Doribax
The FDA extended the review period by three months to provide time for a full review of the application after receiving additional information it had requested from 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).