Emerging Company Profile: The US biotech is advancing a pipeline of precision medicines targeting menin and farnesyltransferase for liquid and solid tumors, respectively, building on the work of two pioneering companies in the KRAS space.

More sponsors are submitting applications around the same time requiring the agency to make complicated decisions about exclusivity and whether approval of subsequent applications is barred, FDA attorney says.

Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a recent analysis of FDA approval decisions since 2021.

Lawsuit argues FDA wrongly determined that Avadel’s Lumryz is ‘clinically superior’ to Xywav because of once-nightly dosing. FDA’s Division of Neurology revised its initial opinion based on views of CDHR’s sleep team and additional input from the agency’s orphan drug office.