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New orphan drug, CSL’s garadacimab, cleared for hereditary angioedema

June 17, 2025

Following a complete response letter issued last October over CMC issues, CSL Behring LLC gained U.S. FDA approval June 16 of its humanized anti-factor XIIa monoclonal antibody, garadacimab (CSL-312), to prevent hereditary angioedema attacks.

BioWorld Regulatory Dermatologic Monoclonal antibody Asia-Pacific Australia U.S. FDA

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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...

TL1A is overexpressed in hidradenitis suppurativa

BioWorld Science

Despite the availability of advanced therapeutic options, about 40%-50% of patients with hidradenitis suppurativa do not achieve significant improvement in...

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...

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...