Regen BioPharma Prepares Response For FDA Regarding Its Orphan Drug Application for HemaXellerate
Globenewswire·2025-09-16 12:00
SAN DIEGO, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Regen BioPharma, Inc. (OTC PINK: RGBP) and (OTC PINK: RGBPP) today announced the Company is in the process of addressing comments received by the U.S. Food and Drug Administration (FDA) in connection with the Company’s recent submission of an Orphan Drug Application (ODA) to the FDA for HemaXellerate, its lead therapeutic candidate for the treatment of aplastic anemia. Aplastic anemia is a rare and potentially life-threatening bone marrow disorder. The Company i ...