Only two breakthrough-designated novel agents remain on the US FDA drugs center’s 2023 user fee calendar, while CBER stacks up on vaccines and gene therapies under both BTD and RMAT programs.

Highlights of recent submissions for approval from the Pink Sheet’s US FDA Performance Tracker

DOJ and Chamber of Commerce attorneys argue over whether Chamber has standing to sue and whether AbbVie has suffered harm meriting a preliminary injunction to halt the program. With Medicare’s Oct. 2 deadline looming, Judge Newman said he would issue a decision ‘as quickly as we can.’

Ahead of Friday’s hearing on US Chamber of Commerce's suit against HHS, attorneys discuss potential remedies and carveouts to Inflation Reduction Act's drug price negotiation provisions, harms to industry that may support a preliminary injunction, and what would prompt Supreme Court review.