Response process
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
Bavarian Nordic’s Mpox Vaccine Demonstrates Equivalent Efficacy in Teens and Adults: NIH Study
Mpox vaccine, Bavarian Nordic, MVA-BN vaccine, Teenagers, Adults, Antibody response, Safety, Efficacy, NIH study
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
Johnson & Johnson Highlights Promising Combination of TALVEY and TECVAYLI for Relapsed or Refractory Multiple Myeloma
TALVEY (talquetamab), TECVAYLI (teclistamab), Relapsed or Refractory Multiple Myeloma (RRMM), Bispecific Antibody Combination, Extramedullary Disease (EMD), High Response Rates, Durable Responses
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