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BioWorld - Wednesday, December 31, 2025
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» ODAC to weigh in on unconfirmed accelerated approvals
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ODAC to weigh in on unconfirmed accelerated approvals
March 11, 2021
By
Mari Serebrov
Oncology drugs that have racked up a number of indications through accelerated approvals are losing some of those indications as the result of an FDA industrywide evaluation of confirmatory trials that didn’t back up the approvals.
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