The US Food and Drug Administration (FDA) on Monday issued a statement explaining how the agency can facilitate the development of investigational products to diagnose, treat and prevent emerging ...

The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on ...

BioticsAI CEO Robhy Bustami joined Isabelle Johannessen on Build Mode to discuss how the company has navigated a highly ...

When pharmaceutical companies develop a novel drug for the market, several steps are required to assess and regulate its safety, effectiveness, manufacturability, and reliability. These processes, and ...

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 ...