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The European Medicines Agency acted properly in rejecting a UK-based pharmaceutical company’s over-the-counter migraine medicine, the European ombudsman says. Read More
The race to create an abuse-deterrent version of a once-daily analgesic is heating up, with Purdue Pharma taking the lead in its competition with Zogenix’s controversial painkiller Zohydro ER. Read More
Some melanoma patients in the EU will now have access to GlaxoSmithKline’s Mekinist, following the European Commission’s approval of the drug as a single agent for patients with unresectable or metastatic disease fueled by a BRAF V600 mutation. Read More
The FDA has granted breakthrough therapy designation to Amgen’s bispecific T cell engager (BiTE) antibody blinatumomab for the treatment of a rapidly progressing blood and bone marrow cancer, paving the way for speedy development and review of the drug. Read More
Allergan got bad and good news recently from the FDA, with the agency rejecting for a second time the company's migraine treatment Semprana due to manufacturing issues but approving a new indication for its eye treatment Ozurdex. Read More
Drug approved under the qualified infectious disease products designation, created in 2012 to spur development of drugs for increasingly resistant pathogens. Read More