1xbet 로그인., Ltd.
Otsuka announces that subsidiary Astex Pharmaceuticals' NDA for ASTX727 (oral C-DEC), 1xbet 로그인, has been accepted for priority review by the U.S. FDA
Astex Pharmaceuticals, Inc., a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., has been informed by 1xbet 로그인 U.S. Food and Drug Administration (FDA) that 1xbet 로그인 agency has accepted for priority review Astex's new drug application (NDA) for oral C-DEC, a combination of 1xbet 로그인 oral hypomethylating agent cedazuridine and decitabine.
Oral C-DEC is in development as a treatment 1xbet 로그인 adults with previously untreated intermediate- and high-risk myelodysplastic syndrome (MDS), including chronic myelomonocytic leukemia (CMML).
1xbet 로그인 NDA submission is supported by data from 1xbet 로그인 ASCERTAIN phase 3 study.
1xbet 로그인 FDA grants 1xbet 로그인 Priority Review Designation to applications for drugs that, if approved, would provide significant improvements in 1xbet 로그인 safety and effectiveness of 1xbet 로그인 treatment, diagnosis or prevention of serious conditions.
1xbet 로그인 Priority Review Designation means that 1xbet 로그인 FDA's goal is to take action on an NDA application within six months (compared to 1xbet 로그인 ten months under standard review).
Oral C-DEC is an investigational compound and is not currently approved in any country.