The FDA’s latest label change for voclosporin adds data demonstrating its safety and efficacy, as well as a sustained renal response, in patients with lupus nephritis through three years of treatment.
Second Biosimilar Equivalent to Adalimumab
A recent study established the equivalency of BI 695501, a biosimilar, to its reference product, adalimumab, for treating patients with rheumatoid arthritis…
FDA’s ‘Breakthrough Drug’ Terminology Confuses the Public
NEW YORK (Reuters Health)—What the Food and Drug Administration calls a ‘breakthrough’ drug is often not the same as what a layperson would call a breakthrough, a new study shows. The FDA uses the term more often, and for smaller advances, than people use it colloquially, and this may lead patients to have unwarranted confidence…
Lupus Nephritis Therapies Compared, Plus Naming Guidance for Biosimilars
Comparing tacrolimus, mycophenolate mofetil and cyclophosphamide, tacrolimus was the most efficacious. Also, biosimilars may soon be easier to differentiate…
Drug Updates
Information on New Approvals and Medication Safety
Drug Updates
Information on New Approvals and Medication Safety
Drug Updates
Information on safety, labeling changes, and pharmaceutical research