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The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended 11 medicines for approval, including one new cell therapy, four new drugs and four biosimilars. Read More
The FDA approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit hyperactivity disorder in pediatric and adult patients, including multiple strengths manufactured by Apotex, Teva, Aurobindo Pharma and Glenmark Pharmaceuticals. Read More
GlaxoSmithKline and ViiV Healthcare redeemed a priority review voucher for their application for a single-tablet antiretroviral regimen of Tivicay (dolutegravir) and Edurant (rilpivirine) for maintenance treatment of HIV-1 infections. The voucher allows for an expedited six-month review — cutting four months from the standard review. Read More