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.…
Shots: The US FDA has approved the company’s Vafseo (vadadustat) tablets as a treatment of anemia associated with chronic kidney disease (CKD) in adults on dialysis for at least 3mos. The company, in collaboration with CSL Vifor, will commercialize Vafseo across the US The approval was based on the safety and efficacy results from INNO2VATE…
Shots:Barbara gave a comprehensive view of the P-III (MOMENTUM) clinical study results which evaluates its lead candidate in myelofibrosisSierra is now acquired by GSK (completed on 1st July 2022) resulting in GSK commercializing this prime product once approvedThe interview outlines Sierra’s (now GSK) vision to develop transformative therapies for rare cancersSmriti: Thank…
AstraZeneca presented P-III data of Roxadustat along with unprecedented 41 abstracts from its renal portfolio at American Society of Nephrology Kidney Week 2019, demonstrating its commitment to advancing the care of Chronic Kidney Diseases (CKD) and its complications, affecting millions of people across the globe.On Nov 12, 2019 in an interview with PharmaShots, John…

