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January 10, 2024
The accepted sBLA comes after phase 3 clinical trial results which demonstrated better overall survival, progression-free survival, and confirmed overall response rate than chemotherapy in patients with cervical cancer.
January 10, 2024
The Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) intended to convert the accelerated approval granted to Tivdak (tisotumab vedotin-tftv) in 2021 to full approval for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.
January 9, 2024
TOKYO, Jan. 8, 2024 /PRNewswire/ -- Astellas Pharma Inc. today announced the U.S. Food and Drug Administration issued a complete response letter on January 4, 2024, regarding the Biologics License...
January 9, 2024
– Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy – ...
January 9, 2024
TIVDAK sBLA accepted for priority review, FDA action date is May 9, 2024 Submission based on positive results from global phase 3 innovaTV 301 trial demonstrating overall survival benefit of...
January 9, 2024
Pfizer Inc on Tuesday said that the US Food & Drug Administration has agreed to review its licence application to get full approval for Tivdak in patients with recurrent or metastatic cervical...
January 9, 2024
FDA’s Center for Drug Evaluation and Research (CDER) approved a wide range of therapies in 2023 that will help patients and consumers live better and possibly longer lives.
January 9, 2024
Pfizer and Genmab are seeking full approval for Tivdak® (tisotumab vedotin-tftv) in patients with recurrent or metastatic cervical cancer.
January 6, 2024
The post-hoc analysis of the phase 3 ENHANCE study provides the first published evidence of a correlation between decreases in IL-31, bile acids, and pruritus symptoms in PBC following treatment with an investigational agent.
January 5, 2024
JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that the National Medical Products Administration (NMPA) of China