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.…

ByDipanshu DixitJune 6, 2024

News

Akebia’s Vafseo (Vadadustat) Tablets Gains the US FDA’s Approval to Treat Anemia Due to CKD

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…

ByDipanshu DixitMarch 27, 2024

EXCLUSIVE

Barbara Klencke, CMO at Sierra Oncology (now GSK) Shares Insights on the Significant benefits obtained from the Pivotal Myelofibrosis Study

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…

BySenior EditorJuly 18, 2022

VIEWPOINTS

PharmaShots Interview: AstraZeneca’s Global Medicine Leader John Houghton Shares Insights on Roxadustat in Treating Patients with Anemia Due to CKD at ASN 2019

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…

BySenior EditorNovember 12, 2019

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

Akebia’s Vafseo (Vadadustat) Tablets Gains the US FDA’s Approval to Treat Anemia Due to CKD

Barbara Klencke, CMO at Sierra Oncology (now GSK) Shares Insights on the Significant benefits obtained from the Pivotal Myelofibrosis Study

PharmaShots Interview: AstraZeneca’s Global Medicine Leader John Houghton Shares Insights on Roxadustat in Treating Patients with Anemia Due to CKD at ASN 2019

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

Akebia’s Vafseo (Vadadustat) Tablets Gains the US FDA’s Approval to Treat Anemia Due to CKD

Barbara Klencke, CMO at Sierra Oncology (now GSK) Shares Insights on the Significant benefits obtained from the Pivotal Myelofibrosis Study

PharmaShots Interview: AstraZeneca’s Global Medicine Leader John Houghton Shares Insights on Roxadustat in Treating Patients with Anemia Due to CKD at ASN 2019

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