由于第三方填充/完成制造商的问题,Regeneron的linvoseltamab CRL从FDA获得多发性骨髓瘤治疗. Regeneron's linvoseltamab CRL from FDA for multiple myeloma treatment due to third-party fill/finish manufacturer issue.

美国FDA批准了Regeneron的血液癌症治疗药物linvoseltamab,用于复发性/耐药性多发性骨髓瘤的治疗. Regeneron's blood cancer therapy, linvoseltamab, received a CRL from the US FDA for relapsed/refractory multiple myeloma treatment. 唯一核准的问题涉及第三方填充/加工厂商的核准前检查结果。 The sole approvability issue concerns pre-approval inspection findings at a third-party fill/finish manufacturer. 雷格内龙和FDA正在合作解决这一问题,而该疗法仍在欧盟审查中. Regeneron and the FDA are collaborating to address it, while the therapy remains under EU review.

August 20, 2024

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