Add Yahoo as a preferred source to see more of our stories on Google. The FDA has introduced a new draft guidance The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to ...

The European Medicines Agency (EMA) reports on progress to create a smoother, less wasteful biosimilar development process; and the World Health Organization (WHO) revises its biosimilar development ...

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...

Each major element of the new guidance corresponds to a reform Professor Niazi advocated in peer-reviewed literature and formal citizen petitions to the FDA: Niazi published a critical analysis ...