BMS, Novartis, Akebia and more face FDA approval decisions soon, with big sales on the line

An interesting and varied group of drugs—ranging from two first-in-class cancer therapies to a treatment that removes frown lines—face target dates for potential FDA approvals this month. Many of the decisions bear watching as their status could have far-reaching implications for the industry and for patients.

Take for example Akebia’s vadadustat, which could be the first in its class of HIF-PH oral inhibitors to reach the market in the United States. The drug, which treats the anemia that comes with chronic kidney disease, is due for a March 29 decision and is pegged by analysts with Evaluate to generate sales of $532 million in 2026.