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ATG-022, a Claudin 18.2 ADC, Receives Orphan Drug Designations for the...

Shanghai-based biopharmaceutical company Antengene, confirmed that ATG-022, a Claudin 18.2 (CLDN18.2) antibody drug conjugate (ADC) being developed by the company, has been granted two Orphan Drug Designations (ODD) consecutively by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer. 
Daiichi Sankyo

Daiichi Sankyo Submits Supplemental New Drug Application for Trastuzumab Deruxtecan in...

In a statement earlier today, Daiichi Sankyo confirmed that it has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour...

Orphan Drug Designation for Alteogen’s Antibody-Drug Conjugate for the Treatment of...

Alteogen, a Korea-based biopharmaceutical company focusing on the development and commercialization of novel anticancer drugs such as antibody-drug conjugates, has received an approval for...

Global Phase II Study of DS-8201 in Patients with HER2-Expressing Advanced...

Following initiation of pivotal phase II studies in HER2-positive breast cancer and gastric cancer, the initiation of a third phase II study in colorectal...

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...

U.S. Food and Drug Administration Accepts Investigational New Drug Application for...

The U.S. Food and Drug Administration (FDA) has accepted the AbGenomics International's Investigational New Drug Application or IND for AbGn-107, the company's antibody-drug conjugate or ADC candidate...

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