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Medical Device Network on MSNAliveDx seeks FDA approval for MosaiQ AiPlex CTDplus assayAliveDx has submitted a 510(k) premarket notification seeking approval from the US Food and Drug Administration (FDA) for its ...
Based on clinical trial data, abatacept was not associated with increased malignancy risks in RA or PsA; observational data indicated a higher risk vs other b/tsDMARDs.
Rheumatoid arthritis (RA) and lupus both cause joint ... and the European League Against Rheumatism (EULAR). Systemic lupus erythematosus (SLE) is the most common type of lupus.
The following is a summary of “Evaluating the Real-World Use of Topical Diclofenac Sodium Gel 1% Using US Longitudinal Electronic Health Records Database: A study supporting OTC switch,” published in ...
Biosimilar challenges include complex manufacturing processes and regulatory obstacles, offset by less regulated market ...
The Switzerland-based firm's MosaiQ AiPlex Connective Tissue Diseases (CTDplus) assay is used to aid the diagnosis of autoimmune diseases.
AliveDx announces it has submitted 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the MosaiQ AiPlex® Connective Tissue Diseases (CTDplus) microarray. The MosaiQ ...
Tofidence is indicated in certain patients for the treatment of moderate to severe rheumatoid arthritis, giant cell arteritis ...
Organon (OGN) announced that it has acquired from Biogen (BIIB) regulatory and commercial rights in the U.S. for Tofidence, a biosimilar to ...
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