FDA reviewers were so frustrated by AstraZeneca's application for Imfinzi as a treatment before and after surgery for resectable non-small cell lung cancer (NSCLC) that they voted for a ret
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 EMA's human medicines committee has recommended against approval of Eisai and Biogen's Alzheimer's disease therapy Leqembi, after regulators in the US, China and Japan gave a green ligh