Edition:
United Kingdom

FDA Says Granted Accelerated Approval To Janssen's Balversa


Friday, 12 Apr 2019 

April 12 (Reuters) - FDA::FDA APPROVES FIRST TARGETED THERAPY FOR METASTATIC BLADDER CANCER.FDA - GRANTED ACCELERATED APPROVAL TO BALVERSA (ERDAFITINIB).FDA - BALVERSA WAS ALSO GRANTED BREAKTHROUGH THERAPY DESIGNATION.FDA - ALSO APPROVED THERASCREEN FGFR RGQ RT-PCR KIT, DEVELOPED BY QIAGEN MANCHESTER FOR USE AS COMPANION DIAGNOSTIC WITH BALVERSA FOR INDICATION.