Complete
FDA Rejects Milestone Pharmaceuticals’ Etripamil Nasal Spray for PSVT
Etripamil, Cardamyst, PSVT, FDA rejection, Complete Response Letter, manufacturing issues, Milestone Pharmaceuticals
FDA Issues Complete Response Letter for Zealand Pharma’s Glepaglutide in Short Bowel Syndrome Treatment
Zealand Pharma, Glepaglutide, GLP-2 analog, Short Bowel Syndrome (SBS), FDA rejection, Complete Response Letter
FDA Issues Complete Response Letter to Astellas for IZERVAY Supplemental New Drug Application
FDA, Astellas, IZERVAY, geographic atrophy, age-related macular degeneration, Complete Response Letter, supplemental New Drug Application
FDA Issues Complete Response Letter to Camurus for Acromegaly Treatment Due to Third-Party Manufacturing Deficiencies
FDA, Camurus, Complete Response Letter, Acromegaly, Manufacturing Issues, Third-Party Manufacturer, CAM2029
FDA Delays Approval of Zealand Pharma’s Dasiglucagon for Congenital Hyperinsulinism Due to Third-Party Manufacturing Issues
Zealand Pharma, dasiglucagon, congenital hyperinsulinism, FDA, Complete Response Letter, third-party manufacturing issues
FDA Rejects Novo Nordisk’s Once-Weekly Insulin Icodec for Diabetes Treatment
FDA, Novo Nordisk, Icodec, Weekly Insulin, Diabetes Treatment, Type 1 Diabetes, Type 2 Diabetes, Complete Response Letter
FDA Rejects Rocket Pharmaceuticals’ Gene Therapy for Ultra-Rare Immune Disease, Requests Additional Manufacturing Information
FDA, Rocket Pharmaceuticals, Gene Therapy, Leukocyte Adhesion Deficiency-I (LAD-I), Manufacturing Information, Complete Response Letter
FDA Issues Complete Response Letter to Abeona’s Cell Therapy for Rare Skin Disease
FDA, Complete Response Letter (CRL), Abeona, cell therapy, rare skin disease, Epidermolysis Bullosa (EB)