An FDA advisory panel concluded that the limited benefits of Serenity Pharmaceuticals LLC/Allergan PLC’s desmopressin nasal spray for nocturia – essentially cutting down nighttime trips to the bathroom by a few times per week – outweigh its risks and recommended approval.
Allergan’s Nasal Spray For Frequent Nighttime Urination Gets Cautious Panel Nod
Desmopressin's limited efficacy over placebo doesn't dissuade FDA's advisory committee, which votes 14 to 4 in favor of approval even as many suggest indication be narrowed.
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
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March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
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The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.