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Nature Cell wins FDA breakthrough designation of Jointstem

March 25, 2025

Nature Cell Co. Ltd. won U.S. FDA breakthrough therapy designation of its autologous adipose-derived mesenchymal stem cell therapy, Jointstem, March 20, becoming the first Korean company to earn the label in the field of cell therapy.

BioWorld BioWorld Asia Analysis and data insight Regulatory Aging Musculoskeletal Cell therapy Asia-Pacific Japan U.S. Breakthrough therapy FDA

FDA says changes in Dexcom G6, G7 sensors constitute misbranding

BioWorld MedTech

The U.S. FDA’s March 4, 2025, warning letter to Dexcom Inc. is a well-detailed but heavily redacted document explaining the agency’s misgivings about procedures...

Today's news in brief

BioWorld

BioWorld briefs for March 28, 2025.

Today's news in brief

BioWorld MedTech

BioWorld MedTech briefs for March 28, 2025

CMV history cited in DMD liver death on Sarepta’s Elevidys

BioWorld

Wall Street was weighing the gravity of the death from acute liver failure of a patient who was treated for Duchenne muscular dystrophy (DMD) with Sarepta...

UK government abolishes NHS England

BioWorld MedTech

In a move that surprised many across the health care sector, the U.K. government decided to scrap NHS England, the body which runs the national health service...