Breaking News

Tanvex BioPharma USA Achieves Dual U.S. Regulatory Milestones

FDA approves Nypozi and grants BLA acceptance of TX-05.

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Tanvex BioPharma USA, Inc., a contract development and manufacturing organization (CDMO) for biologics and a biosimilars products company, has received U.S. FDA approval for Nypozi (filgrastim-txid), the company’s biosimilar referencing Neupogen,1, to treat chemotherapy-induced neutropenia in cancer patients. The approval marks an important regulatory milestone that was quickly complemented by the FDA’s acceptance of the company’s Biologics License Application (BLA) for TX-05, an investiga...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters