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A Georgia compounding pharmacy ran afoul of the FDA after losing the exemption from agency rules that is extended to compounders that limit their production to filling prescriptions for individual patients, the FDA said in a warning letter. Read More
The European Medicines Agency updated its advice on navigating its centralized pre-authorization procedures to include a section on combination packs of medications. Read More
The FDA opened the doors to a dramatic new method for treating cancer — the genetic modification of a patient’s immune cells to fight the disease — by granting approval to Novartis’ Kymriah. Read More
Xarelto is primarily used to reduce the risk of stroke and systemic embolism, as well as to treat deep vein thrombosis and pulmonary embolism. Read More