Keeping Track: Biosimilar Submissions Galore (And An Approval), Bayer Gets An Oncology Approval, KemPharm Resubmits Apadaz NDA
Executive Summary
The latest regulatory submission news and highlights from our US FDA Performance Tracker.
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FDA Panel To Consider Strategies For Timely Completion Of Accelerated Approval Confirmatory Trials
Confirmatory trials for anti-cancer drugs should be targeted for completion no later than two to four years after accelerated approval is granted, agency says, offering various strategies and factors sponsors should consider to ensure they are conducting studies with due diligence.
Keeping Track Of Withdrawals: Libtayo, Parsaclisib Applications Pulled Due To Postmarketing Issues
Changing therapeutic landscape may have complicated regulatory plans for Regeneron/Sanofi’s PD-1 inhibitor in second-line cervical cancer, while accelerated approval confirmatory trial timeline appears to have been an issue for Incyte’s PI3-kinase inhibitor in lymphoma.
Keeping Track: A Busy Week For Regenerative Medicine, A Surprise Priority Review For Vascepa, And Tazemetostat Aims For Accelerated Approval
The latest drug development news and highlights from our US FDA Performance Tracker.