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 ...
On Monday, the FDA published the draft guidance, “Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software,” which could facilitate drug manufacturers’ ...
BUFFALO, N.Y., Jan. 23, 2023 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a leading biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis and ...
HSINCHU, Dec. 2, 2025 /PRNewswire/ -- Amaran Biotech, a next-generation Contract Development and Manufacturing Organization (CDMO), announced that its self-developed, GMP-grade high-purity vaccine ...
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 ...
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 ...
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