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FDA granted a Qualified Infectious Disease Product designation to MGB-BP-3, developed by MGB Biopharma, for the treatment of Clostridium difficile-associated diarrhea. Read More
Teva intends to meet with the FDA to renew its efforts to launch a generic version of Mylan’s EpiPen by 2018, after many have called into question the price of Mylan’s allergy treatment. Read More
When planning an international clinical trial, setting endpoints that are clinically meaningful across regions and planning ahead for local factors are recommended in draft FDA guidance. Read More
Merck is suspending development of its osteoporosis candidate after an analysis of its Phase III fracture outcomes study demonstrated that the therapy increases the risk of strokes. Read More
FDA granted accelerated approval to Amgen’s Blincyto (blinatumomab) for the treatment of pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Read More