Scioderm to submit rolling NDA to FDA for Zorblisa
A rolling submission is intended to accelerate the review process by enabling review of portions of the NDA by the FDA prior to submission of the complete application.
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).
The intellectual property was developed at the Henry Ford Hospital System, Detroit, Michigan, by Drs. Michael Chopp, Daniel Morris, and Zhenggang Zhang, and in-licensed by RegeneRx Biopharmaceuticals, Inc.
Cara’s formulation of oral CR845 will continue to utilize Enteris’ proprietary oral delivery technology under a renewed and revised Manufacturing and Clinical Supply Agreement. The new agreement includes
VK5211 is an orally available, non-steroidal selective androgen receptor modulator (SARM) being developed for the treatment of patients recovering from non-elective hip fracture surgery. Viking intends to commence