Tag: Fast Track Designation
FDA Grants Fast Track Designation for ARX517 in Metastatic Castration-Resistant Prostate...
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ARX517, a proprietary anti-PSMA antibody-drug conjugate (ADC) investigational being therapy developed by Ambrx for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) upon progression on an androgen receptor pathway inhibitor.
FDA Grants Fast Track Designation to DB-1303 for the Treatment of...
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to DB-1303 a novel antibody-drug conjugates for the treatment of patients with advanced, recurrent or metastatic endometrial carcinoma with HER2 over-expression who have progressed on or after standard systemic treatment.
ESMO 2020: XMT-1536 Shows 34% ORR in Phase I Expansion Study...
Updated interim safety, tolerability, and efficacy data for the ovarian cancer cohort of the ongoing expansion portion of the Phase I study evaluating XMT-1536...
Everest Medicines to Initiate a Registration Study in China for Sacituzumab...
China-based Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative products, address critical unmet medical needs for patients in Greater China and...
