Locally-Delivered Sitaxsentan Designated Orphan Drug for Systemic Sclerosis
TMB-003 is a locally delivered formulation of sitaxsentan, a highly selective endothelin receptor antagonist.
Immune Disorders
FDA Extends Expiration Date of Immunoglobulin Product Cutaquig
The new expiration date for cutaquig is valid for 42 existing lots that were manufactured and distributed in 2019 and 2020.
Belimumab Approved for Lupus Nephritis
Belimumab is already indicated for the treatment of active, autoantibody-positive systemic lupus erythematosus in individuals aged 5 years and over.
Orladeyo Now Available for Hereditary Angioedema
The oral, once-daily treatment will be shipped to patients with a prescription by specialty pharmacy Optime Care, Inc.
No Benefit With Ruxolitinib for COVID-19 Associated Cytokine Storm
The global, double-blind, placebo-controlled RUXCOVID study compared ruxolitinib to placebo, in addition to standard of care, in 432 patients aged 12 years and older with COVID-19 associated cytokine storm.
Antifibrotic Therapy Gets Orphan Drug Status for Systemic Sclerosis
ACE-1334 is a TGF-beta superfamily-based ligand trap designed to bind and inhibit TGF-beta 1 and 3 ligands.
New Study Supports Voclosporin Use in Lupus Nephritis Cases
Pooled analyses from 2 clinical trials show that voclosporin, a novel calcineurin inhibitor, is safe and effective in managing lupus nephritis.
FDA: More Data on Remestemcel-L for Graft Versus Host Disease Needed
In the CRL, the FDA recommended that the Company conduct at least 1 additional randomized, clinical study.
FDA to Review Avacopan for ANCA-Associated Vasculitis
Avacopan is an orally-administered, small molecule designed to selectively block the complement 5a receptor on destructive inflammatory cells such as blood neutrophils.
Newly Diagnosed Lupus Erythematosus Could Potentially Be Drug Induced
A new case of cutaneous lupus erythematosus or systemic lupus erythematosus could potentially be drug induced.
