Avastin’s Breast Cancer Approval Followed CDER Rift On Efficacy
The Center for Drug Evaluation and Research is expected to present a united front supporting withdrawal of Avastin’s (bevacizumab) metastatic breast cancer claim at a June 28-29 hearing.
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Following accelerated approval of Biogen’s Alzheimer’s drug aducanumab in the US, we look back at 10 of the FDA’s most controversial drug approval decisions, from Addyi to Zohydro.
With action imminent on Biogen’s Alzheimer’s drug aducanumab, the Pink Sheet looks back at 10 of FDA’s most controversial drug approval decisions, from Addyi to Zohydro.
If all drugs cleared for accelerated approval succeed in their confirmatory studies, then FDA is being overly conservative in its use of the expedited approval pathway, FDA Office of Hematology and Oncology Products Director Richard Pazdur says at the AACR annual meeting.