The US FDA is urging drug companies to abandon traditional approaches to oncology dosing even if it means slowing down early studies. The trade-off should be faster development times overall, FDA says – but sponsors still seem very wary.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Withdrawal procedure in House consensus bill would require only one advisory committee hearing, instead of potentially two, likely shortening the time to a final decision.

The company will prioritize later-stage R&D, including potential accelerated approval for a second anti-amyloid antibody, while replacing its CEO and cutting Aduhelm commercial operations and other costs.