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 ...

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. Food and Drug Administration ...

MILPITAS, Calif.--(BUSINESS WIRE)--Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II ...

Kexing Biopharm announced that its investigational Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes has successfully completed a Type II Drug Master File (DMF) registration with the U.S.

The agency held a meeting to gather drugmakers' perspectives as it considers a draft guidance on how previously generated ...

The U.S. Food and Drug Administration has declined to approve Scholar Rock's drug for a rare neuromuscular disease, citing ...

The U.S. Food and Drug Administration has declined to approve a higher-dose version of Biogen's drug for a rare genetic ...