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A complete response letter to Otsuka Pharmaceutical from the FDA shot down the company’s application for a drug/device combination product, saying the agency needs more data. Read More
Actavis Laboratories was hit with a two-observation Form 483 after the FDA unearthed potential issues with product storage and recordkeeping. Read More
Despite grave doubts, an Indian high court judge is allowing two drugmakers to market and produce contested biosimilars of Roche’s breast cancer therapy Herceptin. Read More