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Samsung Bioepis’ investigational Humira biosimilar, SB5, demonstrated equivalence to the reference product in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy in a pivotal Phase 3 clinical trial, the South Korean drugmaker said Wednesday. Read More
The agency is revoking requirements regarding inactivated influenza vaccine, allergenic products and the detection of extraneous toxic contaminants. Read More
The FDA Tuesday approved Novartis’ heart failure drug Entresto, which had received priority review and fast track designations to expedite therapies for life-threatening conditions and unmet medical needs. Read More
The FDA has permanently barred an Arlington, Va., distributor from doing business in the U.S. after he was convicted of two felonies for selling counterfeit products. Read More
Early notice of production shutdowns by manufacturers of life-supporting and life-sustaining drugs and biologics have allowed the FDA to avert more than 550 potential drug shortages in the last three years, the agency says in a final rule mandating early notice. Read More
Purdue Pharma has withdrawn its supplemental new drug application for reformulated OxyContin, causing cancelation of an FDA advisory committee meeting to discuss whether postmarket studies of the product’s extended-release tablets show reduced misuse. Read More
Eli Lilly’s lung cancer drug necitumumab improved overall survival when used with two combined chemotherapies, but caused a small uptick in sudden deaths, the FDA says in a preliminary review issued Tuesday. Read More