(RTTNews) - Tasly announced that, in a landmark move for the cell therapy industry, the U.S. Food and Drug Administration has accepted a Device Master File (DMF) describing the first dedicated quality ...

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 ...

HAW RIVER, N.C.--(BUSINESS WIRE)--Andersen Sterilizers and its sister company, contract sterilization specialist Andersen Scientific, were awarded the very first master file in the FDA's 510(k) ...

The US Food and Drug Administration (FDA) on Monday issued draft guidance detailing when a Type V drug master file (DMF) can be used to provide information about Center for Drug Evaluation and ...

TIANJIN, China, Jan. 25, 2026 /PRNewswire/ -- In a landmark move for the cell therapy industry, a Device Master File (DMF) describing the first dedicated quality control standard for Mesenchymal ...

DMF No. 43568 is now active and available for reference in global IND and NDA submissions CHENGDU, China, April 28, 2026 /PRNewswire/ -- C-Ray Therapeutics (Chengdu) Co., Ltd., today announced that ...