TOKYO, Japan & MUNICH, Germany--(BUSINESS WIRE)--Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the European Medicines Agency (EMA) has validated the Type II ...
IntraBio Inc. today announced the submission of a variation application to the European Medicines Agency (EMA) to expand the approved Marketing Authorization Application (MAA) for AQNEURSA ® ...
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) is preparing to trial new timelines for variation applications to “provide greater clarity and more effective monitoring.” NPRA published ...