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 ...
This filing marks a significant milestone, as it extends the FDA-filed manufacturing and quality documentation across two formats of the same core technology: the GDT cells themselves, and the ...
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.
DMFs are regulatory submissions filed with the FDA containing confidential, detailed information about manufacturing, processes, packaging, and stability of APIs to be used in medicinal products for ...
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 ...
CytoNiche Biotech, a pioneer in advanced 3D cell manufacturing technologies, announced a pivotal regulatory milestone in its global expansion strategy. The company’s proprietary 3D RecomTrix ...
CRANBURY, N.J. and SUZHOU, China, July 8, 2026 /PRNewswire/ -- Recently, Porton Advanced proudly announced that its Umbilical Cord-Derived Mesenchymal Stem Cell (UC-MSCs) Cell Bank for exosome ...
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 ...
SL Science Holding Limited a mis en avant le dépôt d'un nouveau Drug Master File auprès de la Food and Drug Administration des États-Unis. Le DMF, enregistré sous le numéro 044612, porte ...