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Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
Like ordinary EMA marketing authorisations, a PUMA approval is valid in all countries of the European Economic Area (the European Union as well as Iceland, Liechtenstein, and Norway). The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children.
Biovest Conducts Meeting with EMA Advancing Process to Seek EU Approval for Cancer Vaccine Key Contributor to Human Genome Project Joins Scientific Advisory Board TAMPA, Fla. & MINNEAPOLIS ...
This process is performed within a legal framework defining the requirements necessary for successful application to the regulatory authority, details on the assessment procedure (based on quality, efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked.
BioMarin Pharmaceutical Inc. (BMRN), a global biotechnology company received the European Medicines Agency (EMA) approval for accelerated assessment of valoctocogene roxaparvovec. BioMarin’s ...
Shares of Moderna, Inc. (MRNA) rose 1.9% to close at $332.11 on Tuesday after the biotechnology company received the European Medicines Agency’s (EMA) approval for the third dose of its COVID-19 ...
In April 2016, a committee at the European Medicines Agency (EMA) recommended marketing approval for its use in children with adenosine deaminase deficiency, for whom no matched HSC donor is available, on the basis of a clinical trial that produced a 100% survival rate; the median follow-up time was 7 years after the treatment was administered.