Landmark FDA Move: First Quality Control Protocol for Mesenchymal Stromal Cells (MSCs) Sets New Therapeutic Standard

In a landmark move for the cell therapy industry, a Device Master File (DMF) describing the first dedicated quality control standard for Mesenchymal Stromal Cells (MSCs) was accepted by the U.S. Food ...
Nasdaq

Lantheus Holdings Announces Submission of Drug Master File for NM-01 in the U.S.

NORTH BILLERICA, Mass.--(BUSINESS WIRE)-- Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global ...
Nasdaq

BIO-TECHNE ANNOUNCES SUBMISSION OF FDA DRUG MASTER FILE FOR EXCELLERATE GMP IPSC EXPANSION MEDIUM SUPPORTING STEM CELL THERAPY

MINNEAPOLIS, Dec. 20, 2023 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for its ...
Morningstar

Akadeum Life Sciences Announces Drug Master File Submission to the US FDA for GMP Microbubble Cell Separation

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 ...
Business Wire

ANP’s Polymeric Drug Excipient Drug Master File (DMF) Accepted and Published by the U.S. Food and Drug Administration (FDA)

NEWARK, Del.--(BUSINESS WIRE)--ANP Technologies, Inc. (ANP) announced that its drug master file (DMF) on its novel, nano-encapsulating polymer-based drug excipient, ANP001B has been accepted and ...
La Grande Observer

GeminiBio Submits Drug Master File (DMF) to FDA

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 ...
Seeking Alpha

BWXT Medical Submits Drug Master File for Actinium-225 API to U.S. Food and Drug Administration

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 ...
Business Wire

ARTMS Inc. Submits Drug Master File for the First Ever Multi-Curie Production of Gallium-68 with ARTMS’ Solid Target Solution on Medical Cyclotrons

BURNABY, British Columbia--(BUSINESS WIRE)--ARTMS Inc. (ARTMS) is pleased to announce the submission of a Drug Master File (DMF) to the FDA for the high-volume production of Gallium-68 (68 Ga) with ...