FDA Approvals: RUBRACA & CDxBRCA test, DEXCOM G5, AEROFORM – Drug and Device Digest
FDA BRIEF: Week of December 19, 2016 RUBRACA (rucaparib) tablets, Clovis Oncology, Boulder, CO, USA FoundationFocus CDxBRCA test, Foundation Medicine Inc. Cambridge, MA INDICATION: Monotherapy for patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic …
FDA Approvals: RUBRACA & CDxBRCA test, DEXCOM G5, AEROFORM – Drug and Device Digest Read More »