BioSpace

RoslinCT and Ayrmid Ltd. Announce Expansion of Strategic Partnership to Manufacture Omisirge® (omidubicel-onlv) for Second FDA-Approved Indication in Severe Aplastic Anemia (SAA)

BOSTON--(BUSINESS WIRE)--Ayrmid Ltd., the parent company of Gamida Cell Inc., a pioneering cell therapy company transforming cells into powerful therapeutics, and RoslinCT, a global leader in cell and ...
Medscape

FDA OKs First Cell Therapy for Severe Aplastic Anemia

The FDA has approved omidubicel-onlv (Omisirge, Gamida Cell Ltd.) as the first hematopoietic stem cell transplant therapy for patients with severe aplastic anemia (SAA). Specifically, omidubicel is ...
Yahoo

FDA approves first stem cell therapy to treat severe aplastic anemia

Dec. 8 (UPI) --The U.S. Food and Drug Administration on Monday announced the approval of the first hematopoietic stem cell transplant therapy to treat patients with rare but severe aplastic anemia.
Monthly Prescribing Reference

Cell Therapy Omisirge Approved for Severe Aplastic Anemia

Study findings showed 86% of patients had early and sustained neutrophil recovery at 100 days. The Food and Drug Administration (FDA) has approved Omisirge ® (omidubicel-onlv) for adults and pediatric ...
WebMD

Omisirge: A New Cell Therapy for Severe Aplastic Anemia and Blood Cancers

What Is Omisirge, and Why Does It Matter? Omisirge (omidubicel-onlv) is a type of cell therapy made from umbilical cord blood. It helps your body make new blood cells after a stem cell transplant.
Morningstar

FDA approves Omisirge(R) as First Approved Cell Therapy to Treat Severe Aplastic Anemia

DUBLIN, IE AND LONDON, UK / ACCESS Newswire / December 5, 2025 / Ayrmid Ltd. ("Ayrmid" or the "Company"), the parent company of Gamida Cell Inc., a leader in cell therapy innovation announces that it ...
WSMV

Nashville firefighter diagnosed with serious, rare blood disorder

GREENBRIER, Tenn. (WSMV) - The Greenbrier Fire Department is rallying behind a Tennessee firefighter after he was diagnosed with a rare and serious blood disorder. Nashville firefighter Ethan Stinson ...
Medical Xpress

Hemic and Lymphatic Diseases: News and Research on Anemia, Aplastic

The U.S. Food and Drug Administration has approved Omisirge (omidubicel-onlv) as the first hematopoietic stem cell transplant therapy to treat patients with severe aplastic anemia (SAA). New research ...
Morningstar

Gamida Cell Presents Positive Initial Results on Treating Severe Aplastic Anemia (SAA) with Omidubicel

Ayrmid Ltd. (“Ayrmid” or the “Company”), the parent company of Gamida Cell Inc., a cell therapy pioneer working to turn cells into powerful therapeutics, announced positive interim study results for ...
Monthly Prescribing Reference

Omidubicel Gets Priority Review for Severe Aplastic Anemia

A Prescription Drug User Fee Act target date of December 10, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics ...
Medscape

Can Eltrombopag Transform Aplastic Anemia Care?

Eltrombopag combined with immunosuppressive therapy in pediatric patients with severe aplastic anemia achieved a 54.9% overall response rate at 26 weeks, with a 71.4% response in relapsed/refractory ...