Complete Response Letter
Xspray’s Dasynoc Faces FDA Approval Delay Due to Contract Manufacturing Issues
Dasynoc; Xspray Pharma; FDA; Complete Response Letter; manufacturing issues; good manufacturing practice; contract manufacturer; chronic myeloid leukemia; acute lymphoblastic leukemia; drug approval process
Genentech’s $700M North Carolina Plant and Telix’s FDA CRL Update
Genentech; Roche; North Carolina; manufacturing facility; $700 million; Holly Springs; metabolic medicines; obesity treatments; biomanufacturing; Telix; FDA; Complete Response Letter (CRL); imaging agent
FDA Rejects PTC’s Vatiquinone Application for Friedreich’s Ataxia, Requests Further Studies
FDA rejection; PTC Therapeutics; vatiquinone; Friedreich’s ataxia; complete response letter; drug efficacy; additional clinical studies