Health news
The Food and Drug Administration (FDA) has granted Orphan Drug designation to efzofitimod (ATYR1923) for the treatment of systemic sclerosis. Efzofitimod is a potential first-in-class selective modulator of neuropilin-2 that is designed to downregulate innate…
The Food and Drug Administration (FDA) has approved an extended shelf life for both Asceniv (immune globulin intravenous [human] – slra) 10% Liquid and Bivigam® (immune globulin intravenous [human]) 10% Liquid from 24 to 36…
Several lots of immune globulin products have been voluntarily withdrawn as a precautionary measure due to reports of allergic/hypersensitivity type reactions, some of which were considered medically significant. The Immune Globulin Intravenous (IGIV) products mentioned…
Lilly has decided to discontinue the phase 3 development program for baricitinib in adults with active systemic lupus erythematosus. The decision was made based on data from 2 pivotal phase 3 trials, SLE-BRAVE-I (ClinicalTrials.gov Identifier:…
The Food and Drug Administration (FDA) has granted Orphan Drug designation to ATYR1923 for the treatment of sarcoidosis. Sarcoidosis is a rare inflammatory disease characterized by the formation of granulomas in the body, most commonly…
The Food and Drug Administration has approved the Biologics License Application for Rethymic® (allogeneic processed thymus tissue-agdc), a one-time regenerative tissue-based therapy for immune reconstitution in pediatric patients with congenital athymia. Rethymic is intended to…
The Food and Drug Administration has approved Tavneos (avacopan) as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy including…
The Food and Drug Administration has approved Jakafi® (ruxolitinib) for the treatment of chronic graft-versus-host disease (GVHD) after failure of 1 or 2 lines of systemic therapy in patients 12 years of age and older.…
Jacobus Pharmaceutical Company is voluntarily recalling 3 lots of Ruzurgi® (amifampridine) 10mg tablets due to yeast, mold, and aerobic bacterial contamination based laboratory test results. The 3 recalled lots of Ruzurgi 10mg tablets; NDC 49938-110-01,…
The Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application for abatacept (Orencia) for the prevention of moderate to severe acute graft versus host disease (aGvHD) in patients 6 years…
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