Health Archive

CSOFT’s health sciences blog aims to provide a better understanding of complex diseases, and regulatory polices from conducting experiments to introducing new type of drugs into the market.

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First CAR-T by Gilead and Kite Approved by FDA

Gilead Sciences and Kite Pharma's Yescarta (axicabtagene ciloleucel), the first chimeric antigen receptor (CAR) T-cell therapy approved by the U.S. Food and Drug Administration (FDA) for adult patients diagnosed with follicular lymphoma (FL). Follicular lymphoma is...

FDA Provides Guidance on Switches to Container Closure

The U.S. Food and Drug Administration (FDA) provided guidance that addresses changes to the supply chain due to COVID-19, including its regulatory process for manufacturing and controls (CMS) and chemistry. Materials like glass vials, stoppers, test swabs, and...

FDA Makes Recommendations for COVID-19 Variants

The U.S. Food and Drug Administration (FDA) has revealed recommendations for drug developers and diagnostic test makers to address the efficacy and overall performance of their products in consideration of the COVID-19 variants. The updates in recommendations are...

FDA Approves First Ever 3D-Printed Bone Replacement

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has granted approval for the first customized 3D-printed bone replacement. The device, named Patient Specific Talus Spacer, is the only 3D-printed device in the world, and...

AstraZeneca-Oxford COVID-19 Vaccine is Granted EUA by WHO

The World Health Organization (WHO) announced yesterday (2/15) its approval of emergency use authorization (EUA) of the AstraZeneca-Oxford COVID-19 vaccine. The vaccine is currently approved in the UK and EU, and the WHO’s approval opens more doors for other nations...