A Drug Causes Hundreds of Deaths and Millions of ADEsAn investigation into Actemra (tocilizumab) has uncovered hundreds of serious adverse drug events, but the drug's labeling has not been changed.
FDA approves tocilizumab, first therapy for GCA
FDA approves tocilizumab, first therapy for GCAThe FDA recently granted regulatory approval for tocilizumab (Actemra, Genentech), the first approved therapy for the treatment of adults with giant cell arteritis.
New rheumatoid arthritis therapies are comingFour new drugs and a biosimilar should be on your radar.
Real-world Actemra data show lower rate of some SAEs vs. clinical trials in RAA study of tocilizumab (Actemra) in the treatment of rheumatoid arthritis (RA) found that the number of serious adverse events (SAEs) found in postmarketing data were similar to other populations from clinical trials and epidemiology data.
Actemra gets breakthrough therapy designation for sclerodermaThe FDA has granted breakthrough therapy designation to tocilizumab (Actemra, Genentech) for the treatment of systemic sclerosis, a rare and potentially life-threatening disease with no FDA-approved therapy.
FDA actions in brief