The agency’s Pharmacovigilance Risk Assessment Committee made recommendations on the risk of multiple sclerosis treatments, injectable methylprednisolone medicines, and the use of gadolinium contrast agents.

The assay assesses the ability of antibodies to neutralize the Ebola virus.

Patheon will add spray drying, sterile manufacturing, and packaging capabilities to four facilities.

A new study predicts a potential disconnect between regulatory science and biotechnology product development, unless regulators scan the horizon for new developments and consider new potential risk pathways.