manufacturing issues – Talk Bio

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FDA Declines Approval of Ultragenyx’s Sanfilippo Gene Therapy Due to Manufacturing Issues

2 weeks 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

7 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