It Was Inevitable: FDA Inspection Delay Postpones BMS’s Liso-Cel Approval
Approval By Year-End Required For CVR Payout To Celgene Shareholders
Bristol Myers Squibb confirmed that approval for lisocabtagene maraleucel (liso-cel) will be delayed by the US FDA’s COVID-19-related restrictions on travel for manufacturing facility inspectors.
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Two complaints allege BMS deliberately delayed approval of non-Hodgkins lymphoma treatment to avoid $6.4bn contingency payment. Former FDA reviewer is expert for plaintiffs in securities class action arguing that similar cell therapies Yescarta and Kymriah were approved twice as fast.
The FDA will take three more months to review mavacamten, a treatment for hypertrophic cardiomyopathy that BMS expects to be one of the company’s next blockbusters.
US FDA 'resilience' report charts how inspection backlog grew and impacted approvals and compliance follow-up.