FDA flexes its new accelerated approval authorities, hoping to ...
FDA rejected Regeneron's applications for accelerated approval due to the absence of a confirmatory study, signaling potential use of new 2022 authority, possibly facing criticism for delaying serious disease treatments.
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FDA flexes its new accelerated approval authorities, hoping to ...
FDA rejected Regeneron's applications for accelerated approval due to the absence of a confirmatory study, signaling potential use of new 2022 authority, possibly facing criticism for delaying serious disease treatments.