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Pride of New Chinese Medicine, Icaritin To Be Included in the Priority Review as the First-line Treatment for Hepatocellular PharmaSources/Dopine
May 25, 2021
CDE official website recently disclosed that the marketing application of the Category 1.2 innovative traditional Chinese medicine "Icaritin" of Shenogen Pharma Group/Kangerfu Pharmaceutical would be included in the priority review as scheduled
FDA grants priority review for Merck’s Ebola Vaccine biospectrumasia
September 18, 2019
The Prescription Drug User Fee Act (PDUFA), or target action date, is set for March 14, 2020. In July 2016, the FDA granted Breakthrough Therapy Designation to V920.
Epizyme Announces NDA Acceptance, Priority Review for Tazemetostat americanpharmaceuticalreview
July 26, 2019
Epizyme announced the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for accelerated approval of tazemetostat, its lead investigational agent.
Imported Drugs Approved through Priority Review in 2018 PharmaSources/zhulikou431
January 23, 2019
A memorandum of policies and imported drugs approved through priority review in 2018
Sanofi's controversial Dengvaxia picks up FDA priority review fiercepharma
December 11, 2018
Sanofi has weathered controversy with its world-first dengue vaccine, Dengvaxia, but the company is pressing ahead...
Sanofi's controversial Dengvaxia picks up FDA priority review fiercepharma
December 04, 2018
Sanofi has weathered controversy with its world-first dengue vaccine, Dengvaxia, but the company is pressing ahead, and on Tuesday said the FDA had not only accepted its application for approval, but also granted a priority review.
FDA Grants Priority Review to Baloxavir Marboxil for Influenza americanpharmaceuticalreview
June 27, 2018
Genentech announced the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for baloxavir marboxil as a single-dose
Priority review for Astellas’ AML drug pharmatimes
June 06, 2018
Astellas Pharma’s gilteritinib is under priority review in the US as potential treatment for adults with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation.
FDA grants priority review to Roche's cancer immunotherapy TECENTRIQ (atezolizumab) for initial treatment of people with a specific type of metastatic lung cancer worldpharmanews
May 11, 2018
Roche announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for TECENTRIQ® (atezolizumab),
Update on Priority Review by CDE: Biggest Bright Spot Being the Inclusion of Novartis’ LCZ696 cccmhpie
January 31, 2018
CDE publicized on December 2 the twelfth batch of registration applications of pharmaceutical products to be included in the priority review procedure, with 32 acceptance numbers in total included in the list.

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