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BioRay’s IND Application for BRY812, Accepted by the China National Medical...

The China National Medical Products Administration (NMPA) has accepted the Investigational New Drug (IND) application for BRY812, a novel antibody-drug conjugate (ADC) targeting human LIV-1 for the treatment of advanced malignant tumors (Acceptance No. CXSL2300366).  The investigational drug is being developed by Shanghai-based BioRay Pharmaceutical Co.

Sutro Confirms IND for Second Cell-Free ADC Targeting Anti-Folate Receptor-α for...

Sutro Biopharma confirmed that the U.S. Food and Drug Administration (FDA) has concluded their 30-day review of the Investigational New Drug (IND) application for...
Manufacturing

Antibody Drug Conjugate Development: Keys to Rapid IND Submission and Approval

Antibody drug conjugates (ADCs) are a relatively new type of drug that combines the targeting ability of a biologic with a highly potent cytotoxic...

U.S. FDA Accepts Investigational New Drug Application for Mersana’s Lead Antibody-Drug...

The U.S. Food and Drug Administration (FDA) cleared Mersana Therapeutics’ Investigational New Drug (IND) application to begin Phase I clinical trials for its lead...