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March 19, 2018
The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.
March 16, 2018
The agency announced proposed research studies on how healthcare providers and patients understand drug promotional materials.
March 09, 2018
The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen's multiple sclerosis drug Zinbryta (daclizumab beta).
March 08, 2018
The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.
March 07, 2018
The agency has approved a new HIV treatment for patients with "limited treatment options".
March 02, 2018
Manufacturers face demands for timely information on clinical studies, product recalls, and approvals.
FDA enforcement efforts and drug approvals trend upward.
Drug companies must consider all factors impacting the cost of drugs, including high costs of early development stages.
February 23, 2018
The agency clarifies recommendations found in ICH Q11 about chemical entities and biotechnology entities.
February 21, 2018
The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.