Fda approved gene therapies 2020. . Despite these hardships, we have approved many new therapies that will advance health for the American public. This includes the first FDA-approved drug for the treatment of patients with COVID-19. Approvals were analyzed by regulatory designations and therapeutic areas, with a focus on RMAT designation, introduced in 2016 to expedite advanced therapy approvals. This is the second highest total ever, falling Oct 20, 2020 · Gene and cell therapies are of particular interest because of the steep technology curve driving the technology platform. Presently, the gene therapy landscape stands adorned with 22 approved in vivo and ex vivo products, including IMLYGIC, LUXTURNA, Zolgensma, Spinraza, Patisiran, and many more. Mar 29, 2025 · Data on FDA-approved Cell and Gene Therapies (2020–2024) were sourced from the FDA's public database. Mar 20, 2023 · CBER has approved both cellular and gene therapy products – a list of these products may be found on the Approved Cellular and Gene Therapy Products webpage. Recent advances in gene therapies offer novel therapeutic options for many diseases that are otherwise resistant to pharmacologic treatment. Despite the disruptions caused by COVID-19, the FDA’s Center for Drug Evaluation and Research (CDER) approved 53 novel therapeutics in 2020. The gene and cell therapy industry is characterized by numerous small, competitive, agile businesses; each with a unique toolset. exylr lho jaz ebel cbqa tiau hsgl cgzf agr uctnml