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Cardiologs Unveils New Solution to Enable Use of Smartwatches for Remote Patient Monitoring

Cardiologs Unveils New Solution to Enable Use of Smartwatches for Remote Patient Monitoring
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U.S. FDA Grants Full Approval of REZUROCK(TM) (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD)


U.S. FDA Grants Full Approval of REZUROCK(TM) (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD)
ACCESSWIRE
17 Jul 2021, 04:31 GMT+10
- REZUROCK is approved for the treatment of adult and pediatric patients 12 years and older with cGVHD after failure of at least two prior lines of systemic therapy
-
NEW YORK, NY / ACCESSWIRE / July 16, 2021
/ Kadmon Holdings, Inc. (Nasdaq:KDMN) today announced that the U.S. Food and Drug Administration (FDA) has approved REZUROCK
™ (belumosudil) 200 mg once daily (QD) for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. The FDA granted Breakthrough Therapy designation and Priority Review for REZUROCK and reviewed the New Drug Application (NDA) under the Real-Time Oncology Review (RTOR) pilot program. The FDA approved this NDA six weeks ahead of the Presc ....

United States , Stephanie Lee , Corey Cutler , Harlanw Waksal , Ellen Cavaleri , Oncology Center , Drug Administration , Professor Of Medicine At Harvard Medical School , Exchange Commission , Adult Stem Cell Transplantation Program , Kadmon Holdings Inc , Program At Fred Hutchinson , University Of Washington School Medicine , Dana Farber Cancer Institute , Fred Hutchinson Cancer Research Center , Host Conference Call , Kadmon Holdings , Breakthrough Therapy , Priority Review , New Drug Application , Real Time Oncology Review , Prescription Drug User Fee Act , Associate Professor , Harvard Medical School , Medical Director , Dana Farber Cancer ,

U.S. FDA Grants Full Approval - GuruFocus.com


Confirm
- REZUROCK is approved for the treatment of adult and pediatric patients 12 years and older with cGVHD after failure of at least two prior lines of systemic therapy
-
NEW YORK, NY / ACCESSWIRE / July 16, 2021
/ Kadmon Holdings, Inc. (Nasdaq:KDMN) today announced that the U.S. Food and Drug Administration (FDA) has approved REZUROCK
™ (belumosudil) 200 mg once daily (QD) for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy. The FDA granted Breakthrough Therapy designation and Priority Review for REZUROCK and reviewed the New Drug Application (NDA) under the Real-Time Oncology Review (RTOR) pilot program. The FDA approved this NDA six weeks ahead of the Prescription Drug User Fee Act (PDUFA) goal date of August 30, 2021. REZUROCK is the first and only FDA-approved small molecule inhibitor of ROCK2, a signaling pathway that modula ....

United States , Stephanie Lee , Corey Cutler , Harlanw Waksal , Ellen Cavaleri , Oncology Center , Drug Administration , Professor Of Medicine At Harvard Medical School , Exchange Commission , Adult Stem Cell Transplantation Program , Kadmon Holdings Inc , Program At Fred Hutchinson , University Of Washington School Medicine , Dana Farber Cancer Institute , Fred Hutchinson Cancer Research Center , Host Conference Call , Kadmon Holdings , Breakthrough Therapy , Priority Review , New Drug Application , Real Time Oncology Review , Prescription Drug User Fee Act , Associate Professor , Harvard Medical School , Medical Director , Dana Farber Cancer ,

U.S. FDA Grants Full Approval of REZUROCK(TM) (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD)

U.S. FDA Grants Full Approval of REZUROCK(TM) (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD)
phoenixherald.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from phoenixherald.com Daily Mail and Mail on Sunday newspapers.

United States , Stephanie Lee , Corey Cutler , Harlanw Waksal , Ellen Cavaleri , Oncology Center , Drug Administration , Professor Of Medicine At Harvard Medical School , Exchange Commission , Adult Stem Cell Transplantation Program , Kadmon Holdings Inc , Program At Fred Hutchinson , University Of Washington School Medicine , Dana Farber Cancer Institute , Fred Hutchinson Cancer Research Center , Host Conference Call , Kadmon Holdings , Breakthrough Therapy , Priority Review , New Drug Application , Real Time Oncology Review , Prescription Drug User Fee Act , Associate Professor , Harvard Medical School , Medical Director , Dana Farber Cancer ,

Kadmon Holdings, Inc.: U.S. FDA Grants Full Approval of REZUROCK (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD)

Kadmon Holdings, Inc.: U.S. FDA Grants Full Approval of REZUROCK (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD)
finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.

United States , Stephanie Lee , Corey Cutler , Harlanw Waksal , Ellen Cavaleri , Oncology Center , Drug Administration , Professor Of Medicine At Harvard Medical School , Exchange Commission , Adult Stem Cell Transplantation Program , Kadmon Holdings Inc , Program At Fred Hutchinson , University Of Washington School Medicine , Dana Farber Cancer Institute , Fred Hutchinson Cancer Research Center , Host Conference Call , Kadmon Holdings , Breakthrough Therapy , Priority Review , New Drug Application , Real Time Oncology Review , Prescription Drug User Fee Act , Associate Professor , Harvard Medical School , Medical Director , Dana Farber Cancer ,