HAMPTON, England--(BUSINESS WIRE)--Touchlight, a biotechnology company pioneering enzymatic DNA production to enable genetic medicines, today announced a ground-breaking new milestone for its ...
Recently, Porton Advanced proudly announced that its Umbilical Cord-Derived Mesenchymal Stem Cell (UC-MSCs) Cell Bank for exosome ...
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 ...
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 ...
On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “used to provide confidential, detailed ...
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 ...
Indian companies filed 184 Type II DMFs with the US FDA in Q1 2026 against China's 149, reinforcing the country's leadership ...
The US Food and Drug Administration (FDA) and the generic drug industry have reached agreement on some areas amid negotiations to reauthorize the Generic Drug User Fee Amendments (GDUFA IV) program, ...
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