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 ...

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 ...

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.

OTTAWA, Ontario--(BUSINESS WIRE)-- BWXT Medical Ltd. has submitted a Drug Master File (DMF) to the U.S. Drug and Food Administration (FDA) for No Carrier Added (n.c.a.) Actinium-225 (Ac-225) Active ...

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 ...

TIANJIN, China, Jan. 26, 2026 /PRNewswire/ -- In a landmark move for the cell therapy industry, a Device Master File (DMF) ...

The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies ...

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 ...

Adial Pharmaceuticals signs agreements with Cambrex and Thermo Fisher for AD04 drug production and NDA submission for Alcohol Use Disorder. Adial Pharmaceuticals, Inc. has announced the execution of ...