The FDA has said it will create a rare disease innovation hub to help speed the development of new treatments and build connections between developers and the rare disease community.
Novo Nordisk’s bid to provide a once-weekly basal insulin product for people with diabetes, reducing the number of injections needed, has hit a major hurdle in the US.
The FDA has said it cannot approve MSD and Daiichi Sankyo’s HER3-targeted antibody-drug conjugate (ADC) patritumab deruxtecan because of problems at a third-party manufacturer.
The FDA has published its long-awaited update to guidance to make sure clinical trials more closely reflect the range of patients that might be treated with a new therapy in the real world.