(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 ...
WEST SACRAMENTO, Calif., March 13, 2025 /PRNewswire/ — Gemini Bioproducts, LLC (“GeminiBio”), a biopharma and advanced therapy raw materials supplier, and a portfolio company of BelHealth Investment ...
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 ...
Seemingly in response to the release of a proposed rule for ethylene oxide emissions by the U.S. Environmental Protection Agency, the U.S. FDA has released a second pilot program for device master ...
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) ...
FDA acceptance enables pharmaceutical development partners to directly reference NorthStar no-carrier-added (n.c.a.) Ac-225 DMF in IND and NDA submissions NorthStar’s regulatory and cGMP manufacturing ...
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 ...
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