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The FDA denied Insys Therapeutics’ petition asking the agency to reject abbreviated new drug applications for generics of Syndros (dronabinol) oral solution that rely on a waiver instead of establishing in vivo bioequivalence. Read More
Tecentriq is a monoclonal antibody that binds with a protein, PD-L1, and stops it from camouflaging cancer cells to avoid detection and removal by the immune system. Read More
Celltrion received two complete response letters from the FDA regarding biologics license applications for Truxima (rituximab) and Herzuma (trastuzumab) — biosimilars of Roche`s blockbuster cancer drugs Rituxan and Herceptin. Read More
Committee members noted that the final votes covered multiple issues, including indication and dosage, and said separate votes for each would have been preferable. Read More