{"id":608903,"date":"2024-06-07T17:42:20","date_gmt":"2024-06-07T21:42:20","guid":{"rendered":"https:\/\/platohealth.ai\/at-long-last-geron-wins-fda-approval-of-first-drug\/"},"modified":"2024-06-08T12:56:28","modified_gmt":"2024-06-08T16:56:28","slug":"at-long-last-geron-wins-fda-approval-of-first-drug","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/at-long-last-geron-wins-fda-approval-of-first-drug\/","title":{"rendered":"At long last, Geron wins FDA approval of first drug","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"

ARTICLE | Regulation<\/p>\n

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The 34-year-old company will bring to market Rytelo imetelstat for some patients with myelodysplastic syndromes<\/h2>\n

\n By Paul Bonanos, Director of Biopharma Intelligence<\/span>\n<\/p>\n

June 7, 2024 9:42 PM UTC<\/p>\n<\/div>\n<\/div>\n<\/div>\n

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Geron had to wait 34 years to gain its first FDA approval, but at least the agency didn\u2019t make the company wait until its June 16 PDUFA date.<\/p>\n

Late Thursday, Geron Corp.<\/a> (NASDAQ:GERN) said FDA approved Rytelo imetelstat, its DNA oligonucleotide inhibitor of telomerase, to treat lower-risk myelodysplastic syndromes in patients with transfusion-dependent anemia. The approval covers patients who are relapsed or refractory to, or ineligible for, erythropoiesis-stimulating agents…<\/p>\n