Sep 13, 2021 | News, Regulatory
The US FDA (Food and Drug Administration) has accepted for review BeiGene’s Biologics License Application (BLA) for its anti-PD-1 antibody tislelizumab to treat patients with reoccurring locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)...
Aug 10, 2020 | News, Regulatory
The US Federal Drug Administration (FDA) with the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) has provided guidance today (8/10) for drug-drug interaction studies of therapeutic proteins. The guidance...
