The European Medicines Agency (EMA) on Thursday issued a draft guidance for consultation explaining how sponsors can pursue a parallel Article 58 (EU-M4all) opinion and centralized marketing ...
The European Medicines Agency (EMA) has announced that it has simplified the process by which marketing authorization applications (MAAs) are submitted to the agency, reducing the number of ...
REDWOOD CITY, Calif., Oct. 3, 2012 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative ...
(RTTNews) - Protalix BioTherapeutics Inc. (PLX) and Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., announced the submission of a Marketing Authorization Application or MAA ...
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the intended treatment of acute pain, ...
The European Medicines Agency (EMA) approves Cardiome Pharma's (CRME -2.7%) request to review its Marketing Authorization Application (MAA) for Trevyent (treprostinil PatchPump) for the treatment of ...
The European pharmaceutical market, representing 20% of the global pharmaceutical market, is not a fortress to be feared but an opportunity to be seized. Navigating the European Union’s (EU) ...
Agency sought to answer various procedural questions that could come up during presubmission meetings. EMA recently pulled into one document its answers to regulatory and procedural questions ...
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