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.
KalVista Pharma has filed its first marketing application to the US FDA, seeking approval for its oral plasma kallikrein inhibitor sebetralstat as an oral treatment for hereditary angioedem
An FDA advisory committee has delivered a strong endorsement to Eli Lilly’s Alzheimer’s disease therapy donanemab, voting unanimously that the safety and efficacy of the amyloid-busti
FDA independent advisors have comprehensively voted against the use of Lykos Therapeutics’ therapy for post-traumatic stress disorder (PTSD) based on MDMA, also known as e
The US FDA has started a fresh review of Astellas' zolbetuximab, trying to become the first claudin (CLDN) 18.2-targeting drug to reach the US market, after turning it dow
Eisai and Biogen have filed a rolling biologics license application in the US for a subcutaneous formulation of Alzheimer’s disease therapy Leqembi that was delayed by the