Efzofitimod Granted Orphan Drug Status for Systemic Sclerosis
In preclinical studies, efzofitimod was found to prevent inflammation and fibrosis in multiple animal models of systemic sclerosis and idiopathic pulmonary fibrosis.
In preclinical studies, efzofitimod was found to prevent inflammation and fibrosis in multiple animal models of systemic sclerosis and idiopathic pulmonary fibrosis.
The new expiration date for Asceniv and Bivigam is immediately effective and applies to all existing lots currently in the commercial supply chain and to future production.
The IGIV and IGSC products were voluntarily withdrawn due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.
Based on efficacy results from 2 phase 3 studies, Lilly has decided to discontinue development of baricitinib for lupus.
Results from a phase 1/2 showed that ATYR1923 was safe and well tolerated.
The approval was based on data from the phase 3 ADVOCATE trial, which evaluated Tavneos in 330 adults with newly diagnosed or relapsed ANCA-associated vasculitis.
Rethymic is engineered human allogeneic thymus tissue designed to reconstitute the immune system in pediatric patients with congenital athymia.
The approval was based on data from the phase 3 REACH3 study which included 329 patients.
The tablets may be contaminated with yeast, mold, and aerobic bacterial.
The supplemental Biologics License Application is supported by data from the phase 2 ABA2 trial (ClinicalTrials.gov Identifier: NCT01743131) and real world evidence from a registry trial.