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RemeGen’s RC88 Receives US FDA Fast Track Designation

The United States Food and Drug Administration has granted Fast Track Designation for China-based RemeGen's RC88, a mesothelin (MSLN)-targeting antibody-drug conjugate (ADC). The investigational drug is intended for the treatment of patients diagnosed with platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers.

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...
Featured image: An aerial view of the Yangtze River Delta/Shanghai in the southern Jiangsu province and northern Zhejiang province. Photo Courtecy: 2015 - 2020 © VCG/Gettyimages. Used with permission.

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...

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