Deoxycytidine Kinase Inhibitor Designated Orphan Drug for Optic Neuritis
Optic neuritis is a rare autoimmune disease characterized by the inflammation of the optic nerve.
Immune Disorders
Benlysta Approval Expanded to Include Pediatric Lupus Nephritis
The Food and Drug Administration (FDA) has expanded the approval of Benlysta (belimumab) to include pediatric patients 5 to 17 years of age with active lupus nephritis who are receiving standard therapy. Benlysta, a B-lymphocyte stimulator (BLyS)-specific inhibitor, is also indicated for the treatment of patients 5 years of age and older with active systemic…
Risk for Guillain-Barré Syndrome Up After Ad.26.COV2.S Vaccination
Adjusted rate ratio of 20.56 found in head-to-head comparison of Ad.26.COV2.S with mRNA COVID-19 vaccines
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.
FDA Extends Shelf Life of Immune Globulin Products Asceniv and Bivigam
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.
Jergens Moisturizer Recalled Due to Bacteria Risk
The Pluralibacter gergoviae pathogen is an ongoing problem for the cosmetics industry
Certain Immune Globulin Products Withdrawn Due to Higher Rate of Hypersensitivity Reactions
The IGIV and IGSC products were voluntarily withdrawn due to a higher rate of allergic/hypersensitivity type reactions, some of which were considered medically significant.
Lilly Ends Baricitinib Lupus Program, Provides Update on Atopic Dermatitis sNDA
Based on efficacy results from 2 phase 3 studies, Lilly has decided to discontinue development of baricitinib for lupus.
Biosimilars Could Cut Spending for Biologic Therapy in the US
Increased market growth of biosimilars that are similar to brand-name biologic agents has the potential to reduce spending on prescription drugs
New Drugs Approved in 2021
Visit our New Drug Products page to stay up-to-date on the latest drug approvals.
