DATA GRAPHICS | Data Byte
At least 11 PDUFA dates on deck in December
Five submissions under FDA priority review
November 30, 2021 2:18 AM UTC
At least 11 therapies have PDUFA dates for the month of December, five of which are priority review.
FDA is slated to make its first decision of the month Dec. 4 on a priority review of an sBLA for Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) to treat patients with stage IIb or IIc melanoma following complete resection. Keytruda is already approved for melanoma patients with unresectable or metastatic disease, and for adjuvant treatment of melanoma with lymph node involvement following complete resection...