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FDA continues to build regenerative medicine pathway

Sep. 26, 2025

The U.S. FDA released a trio of draft guidances to help sponsors in developing and monitoring cell and gene therapies, as well as other regenerative medicine therapies.

BioWorld Regulatory Cell therapy Gene therapy U.S. FDA Orphan drug

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IL-22 and TL1A, a robust couple for diagnosing hidradenitis suppurativa

BioWorld Science

Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease with strong association with psoriasis and inflammatory bowel disease (IBD). While some...

Illustration of head with maze that is missing parts

Inhibiting the NLRP3 inflammasome for cognitive impairment, stroke

BioWorld Science

Vascular cognitive impairment and dementia (VCID) and cerebral small vessel disease are among the leading causes of dementia, where inflammation is known to play...

New mechanism of action identified for QC-6352

BioWorld Science

QC-6352 is a small molecule developed to inhibit the histone demethylase 4 (KDM4) that has shown potent antitumoral activity and which has a derivative named...

VST Bio’s VB-001 is neuroprotector after stroke

BioWorld Science

At the recent International Stroke Conference, researchers from VST Bio Corp. and Yale University presented preclinical data regarding VB-001, a monoclonal...