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8 gru 2021 · In February 2021, the FDA accepted the Company’s Biologics License Application (BLA) file for Vicineum for the treatment of BCG-unresponsive NMIBC, granted Priority Review for the BLA and set a...
Our enhanced FDA calendar integrates PDUFA dates, clinical trial primary completion dates, and working capital runway estimates into a single timeline that covers companies publicly traded in the U.S. facing upcoming PDUFA dates.
16 sie 2021 · The FDA has issued a complete response letter to Sesen Bio regarding its biologics license application for Vicineum for the treatment of patients with Bacillus Calmette-Guérin–unresponsive...
Sesen Bio is seeking an accelerated approval for its NMIBC therapy, Vicineum, and the PDUFA date is coming up soon on Aug. 18.
8 mar 2021 · Final approval of the Vicineum brand name is conditional on FDA approval of the Company’s product candidate, oportuzumab monatox. Sesen Bio is currently going through the tradename approval process with the EMA for oportuzumab monatox.
9 maj 2022 · The FDA agreed to a majority of its proposals for a new phase 3 study of its med vicineum at a March 28 meeting, the company revealed in its first-quarter earnings report Monday. Sesen said it...
16 sie 2021 · Sesen Bio reached agreement with the FDA a week ago on the product label for its new bladder cancer drug, one of the final steps for bringing a new drug to the market. Wrapping up product...
