Posts

FDA Rejects Hengrui-Elevar Liver Cancer Drug Combo for Third Time due to Manufacturing Concerns

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Production problems hamper Lantheus bid for FDA approval of LNTH-2501 radiopharma diagnostic kit

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FDA Publishes Complete Response Letters Revealing Manufacturing and Data Gaps as Primary Reasons for Drug Rejections

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Incyte Receives FDA CRL for Zynyz NSCLC Expansion Due to Issues at Novo Nordisk's Catalent Indiana Facility, Becoming Third Affected Company

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Xspray's Dasynoc Faces FDA Approval Delay Due to Contract Manufacturing Issues

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FDA Rejects Scholar Rock's SMA Drug Due to Catalent Indiana Manufacturing Issues

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

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

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