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 ...
The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies ...
LAGUNA HILLS, Calif.--(BUSINESS WIRE)-- PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
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 ...
FDA Ushers in New Program for Drug Products Manufactured Using Innovative Manufacturing Technologies
There are high hopes that the program may help FDA and manufacturers avoid drug shortages, which have been on the rise. In 2022, 150 different manufacturers notified FDA 1,293 times that the ...
VANCOUVER, British Columbia--(BUSINESS WIRE)--STEMCELL Technologies announced it has filed a Type II Drug Master File (DMF) to the Food and Drug Administration (FDA) for the Cellular Therapy Ancillary ...
SAN FRANCISCO (MarketWatch) -- Carrington Laboratories Inc. said on Tuesday that its subsidiary, DelSite Biotechnologies Inc., has filed a drug master file with the Food and Drug Administration. The ...
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