Histogen Announces Update for its HST-002 Dermal Filler Program
Histogen Inc. (HSTO)
Company Research
Source: GlobeNewswire
HST-002 Designated as Drug-Biologic-Device Combination Product HST-001 1b/2a Trial for Androgenic Alopecia in Men on Track for Top Line Data Results in 4Q20 HST-003 IND Submission for Regeneration of Cartilage in the Knee Expected 4Q20 SAN DIEGO, Sept. 29, 2020 (GLOBE NEWSWIRE) -- Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function, today announced that it received communications from the Office of Combination Products (OCM), a division of the United States Food and Drug Administration (FDA), that HST-002 is a drug-biologic-device combination product and will be assigned to the Center for Biologics Evaluation Research (CBER) Office of Tissues and Advanced Therapies (OTAT) as the agency lead for premarket review and regulation. In April of 2020, Histogen had submitted an IDE (Investigational Device Exempt
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