At long last, Geron wins FDA approval of first drug

Geron had to wait 34 years to gain its first FDA approval, but at least the agency didn’t make the company wait until its June 16 PDUFA date.

Late Thursday, Geron Corp. (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...