Submission represents an important step towards establishing the Cellbox Live Shipment Technology as a new standard for warm chain logistic in the cell therapy sector Cellbox customers can now ...

MINNEAPOLIS, Dec. 20, 2023 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ...

Akadeum has been successfully customer-audited per US and EU GMP standards, and the products meet endotoxin, sterility, and viral requirements per USP and ICH standards. As expected for raw materials ...

Hamburg, Germany, September 25, 2023 – Cellbox Solutions GmbH, a leading provider of warm chain logistics solutions for the research, development and shipment of cell-based therapies and cellular ...

Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S.

The "Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions (Oct 9, 2025)" training has been added to ResearchAndMarkets.com's offering. The regulation and control of new or substantially ...

BioCision, LLC have announced that the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health, accepted its Device Master File (MAF) submission for the ThawSTAR ...