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NEWS

Keros Therapeutics Reports First Patient Dosing in P-III (RENEW) Trial of Elritercept for Transfusion-Dependent Anemia in Adults with MDS

Shots:Keros has dosed the first pts in P-III (RENEW) trial assessing elritercept vs PBO in adults with transfusion-dependent anemia with very low, low, or intermediate risk myelodysplastic syndromes (MDS)Dosing triggers a $10M milestone under Keros & Takeda’s Jan 2025 deal, in which Takeda gained global rights to develop, manufacture, & commercialize elritercept (excl.…
July 18, 2025

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Geron
NEWS

Geron’s Rytelo (Imetelstat) Gains the US FDA’s Approval to Treat Myelodysplastic Syndromes (MDS) with Transfusion-Dependent Anemia 

Shots: The US FDA has approved Rytelo to treat low- to intermediate-risk MDS with transfusion-dependent (TD) anemia adults who did not respond to, lost response, or are not eligible for erythropoiesis-stimulating agents (ESA) The approval was supported by the P-III (IMerge) study of Rytelo vs PBO, depicting a 39.8% vs 15.0% RBC-TI rate for 8wks.…
June 6, 2024

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New Drug Designations - August 2023
INSIGHTS+

New Drug Designations – August 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, Japan, and China. This month’s report includes 8 biological drugs, 13 small molecules, 4 cell and gene therapies, 3 diagnostic tests and 5 devices Genprex’ Reqorsa, focused on the treatment of SCLC, is the drug to receive ODD…
September 18, 2023

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