manufacturing issues

FDA Delays Decisions on Regeneron’s Eylea HD Due to Manufacturing Issues

3 weeks ago talkbio0Tagged Biosimilars, Deferred, Edema, Eylea HD, macular, manufacturing issues, Nordisk facility, Pre-filled Syringe, Regeneron, regulatory approval, Retinal Vein Occlusion, United States Food and Drug Administration

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

2 months ago talkbio0Tagged Approved, gene therapy, manufacturing issues, Mucopolysaccharidosis Type IIIA, Regulatory Setback, Response Letter, Ultragenyx, United States Food and Drug Administration, UX111

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

9 months ago talkbio0Tagged Epidermal Growth Factor Receptor, J&J, Malignant neoplasm of lung, manufacturing issues, Mutation, Non-Small Cell Lung Carcinoma, Rejection, Subcutaneous Rybrevant, United States Food and Drug Administration

FDA rejection, J&J, Subcutaneous Rybrevant, Manufacturing issues, Lung cancer drug, Non-small cell lung cancer (NSCLC), Epidermal growth factor receptor (EGFR) mutations