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 ...
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.
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 ...
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 ...
The FDA launched PreCheck pilot program to strengthen U.S. drug supply chain by improving regulatory predictability.
FDA’s new PreCheck pilot streamlines building US pharma manufacturing plants with earlier guidance and faster reviews. Read more here.
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 ...
Vietnam Investment Review on MSN
FDA Establishes First MSC Quality Control Protocol
TIANJIN, China, Jan. 26, 2026 /PRNewswire/ -- In a landmark move for the cell therapy industry, a Device Master File (DMF) ...
The U.S. Food and Drug Administration (FDA) has announced FDA “PreCheck,” a new regulatory program intended to streamline the development and approval of domestic pharmaceutical manufacturing ...
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