Tag: Food and Drug Administration
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.
Withdrawal of FDA’s Accelerate Approved Therapeutic Agents may harm Patients
The United States Food and Drug Administration’s (FDA) program to accelerate approval of some promising therapeutic agents has recently come under fire due to...
A New Generation of Precisely Engineered CD74-Targeting ADCs Receive Orphan Drug...
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for STRO-001 for the treatment of multiple myeloma (MM).
In the United States,...
