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News about "Priority Review "
China's CDE Grants Priority Review to Bayer's FXIa Inhibitor
China’s Center for Drug Evaluation (CDE) grants Priority Review (PR) to Bayer’s FXIa inhibitor, highlighting its potential clinical value in reducing stroke risk.
Priority Review | 08/05/2026 | By News Bureau
U.S. Food and Drug Administration accepts sBLA for Ziihera with Priority Review, backed by Phase III data showing improved outcomes in HER2-positive advanced gastric and gastroesophageal cancers.
Priority Review | 29/04/2026 | By News Bureau
Johnson & Johnson Secures FDA Priority Review for Imaavy in Rare Blood Disorder
Johnson & Johnson moves closer to delivering a first-in-class treatment for Warm Autoimmune Haemolytic Anaemia with FDA Priority Review for Imaavy.
Priority Review | 28/04/2026 | By News Bureau
China Grants Priority Review to Leqembi Subcutaneous BLA
The Priority Review and Approval Procedure has been implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under this procedure, the assessment period is expected to be shortened.
Priority Review | 11/02/2026 | By News Bureau | 139
HUTCHMED Gets Priority Review in China for Fanregratinib NDA
HUTCHMED’s NDA for fanregratinib in second-line intrahepatic cholangiocarcinoma has been accepted in China with priority review status, supported by data from a phase II registration trial addressing a high-unmet-need liver cancer indication.
Priority Review | 02/01/2026 | By News Bureau | 112
FDA Grants Priority Review to Sonrotoclax to Treat Relapsed/Refractory Mantle Cell Lymphoma
The priority review positions sonrotoclax to potentially become the first BCL2 inhibitor approved in the U.S. for relapsed or refractory mantle cell lymphoma, offering a promising new option for patients with this aggressive and hard-to-treat cancer.
Priority Review | 28/11/2025 | By Dineshwori | 191
AstraZeneca's Imfinzi Granted Priority Review by FDA for Early-Stage Gastric and GEJ Cancers
The US Food and Drug Administration (FDA) has accepted AstraZeneca’s supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) and granted Priority Review for the treatment of patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.
Priority Review | 28/07/2025 | By Dineshwori | 194
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