FDA accepts Ardelyx’s NDA resubmission for XPHOZAH
The regulatory agency has determined that the NDA is a class 2 review, which leads to a six-month review period from the date of resubmission. It has set
The products include Baxdela (delafloxacin), Vabomere (meropenem and vaborbactam), Orbactiv (oritavancin), and Kimyrsa (oritavancin). Under the terms of the deal, Xediton Pharmaceuticals will handle the registration and commercialisation
Through the collaboration, Sandoz will gain access to Just – Evotec Biologics’ AI-driven, fully integrated technology platform, which provides development and continuous manufacturing of fully integrated drug substance.
The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility. Nexus Pharmaceuticals stated that the regulatory approval process validates facilities’ compliance with