manufacturing issues
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
FDA Rejects Scholar Rock’s SMA Drug Due to Catalent Indiana Manufacturing Issues
FDA; Scholar Rock; Apitegromab; SMA; Spinal Muscular Atrophy; Catalent Indiana; Complete Response Letter; Manufacturing issues; Drug approval
FDA Delays Decisions on Regeneron’s Eylea HD Due to Manufacturing Issues
FDA delay; Regeneron; Eylea HD; manufacturing issues; Novo Nordisk facility; biosimilars; pre-filled syringe; macular oedema; retinal vein occlusion; regulatory approval
FDA Declines Approval of Ultragenyx’s Sanfilippo Gene Therapy Due to Manufacturing Issues
FDA; Ultragenyx; Sanfilippo syndrome type A; gene therapy; manufacturing issues; UX111; regulatory setback; complete response letter; approval delay
FDA Rejects Subcutaneous Version of J&J’s Lung Cancer Drug Rybrevant Due to Manufacturing Concerns
FDA rejection, J&J, Subcutaneous Rybrevant, Manufacturing issues, Lung cancer drug, Non-small cell lung cancer (NSCLC), Epidermal growth factor receptor (EGFR) mutations