Gallant, an animal health biotechnology company working on ready-to-use stem cell therapies for pets, announced the FDA’s Center for Veterinary Medicine (FDA-CVM) issued a complete letter for the Reasonable Expectation of Effectiveness technical section to support conditional approval of its ready-to-use stem cell therapy for refractory feline chronic gingivostomatitis (FCGS). We are entering the regenerative medicine era—and proud to be leading the way." According to the release, the product under review is Gallant’s investigational new animal drug (INAD), sonruvetcel suspension for injection. Gallant’s cells are sourced from a healthy, specific-pathogen free, FDA-qualified feline donors and then manufactured under current Good Manufacturing Practice conditions. Gallant disclosed that the conditional approval of the product is targeted for early 2026, and if given the conditional approval, this could be the first FDA-conditionally approved and ready to use stem cell therapy in veterinary medicine.