MINNEAPOLIS, Dec. 20, 2023 /PRNewswire/ -- Bio-Techne Corporation (TECH) today announced that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ...
SEATTLE--(BUSINESS WIRE)--Pluristyx, a leading provider of innovative, unmodified, and gene-edited induced pluripotent stem cell (iPSC) lines, submitted a Type II Drug Master File (DMF) to the U.S.
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 ...
MILPITAS, Calif.--(BUSINESS WIRE)--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 ...
FDA’s new PreCheck pilot streamlines building US pharma manufacturing plants with earlier guidance and faster reviews. Read more here.
In a landmark move for the cell therapy industry, a Device Master File (DMF) describing the first dedicated quality control ...
BURNABY, British Columbia, April 01, 2025 (GLOBE NEWSWIRE) -- Telix ARTMS, Inc. (ARTMS), a global leader in radioisotope production technologies, is pleased to announce that the drug master file ...
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