The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to streamline and expedite the biosimilar development process. The regulatory framework has been designed to reduce ...

In this week’s edition of InnovationRx, we look at cheaper biologic drugs, Novo Nordisk’s $2 billion next-gen obesity drug deal, new ways of fighting cancer, and more.

In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

A biosimilar drug manufacturer is concentrating on process optimization to increase uptake of its products in lower-income countries. According to Jeffrey Hausfeld, MD, chairman of the board of ...