Biologics

Post-Market Safety Events for Novel Agents

Post-Market Safety Events for Novel Agents

Nearly one-third of novel therapies have a post-market safety event.

Guidelines for Biologics Use in Lupus by International Panel

Guidelines for Biologics Use in Lupus by International Panel

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A multidisciplinary group of international experts has released recommendations for the use of biologics in patients with systemic lupus erythematosus.

Biomarkers to Predict Dose Reductions, Discontinuation of Rheumatoid Arthritis Treatment?

Biomarkers to Predict Dose Reductions, Discontinuation of Rheumatoid Arthritis Treatment?

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There is little evidence to support the utility of biomarkers to guide clinical care for optimal RA treatment.

FDA Recommendations For Naming of Biologics

FDA Recommendations For Naming of Biologics

The FDA has issued a final guidance document for the naming of reference biological products and biosimilars.

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