Pink Sheet analysis finds big jump in the share of novel approvals that received PDUFA extensions, largely driven by clinical and safety data submissions.

FDA chief scientist encourages Intarcia to request advisory committee review of CDER’s proposal to refuse approval of its drug-device diabetes treatment. CDER again denies Lexicon request for hearing on proposal to deny approval of its SGLT2 inhibitor.

The US FDA’s use of outside expert advisory committees rebounded from historic lows in 2022 – but just barely. Will Commissioner Califf’s ‘update’ of the process finally mean more committee meetings in 2023?

Office of New Drugs grants company’s appeal of complete response letter for tenapanor in dialysis patients, marking a rare sponsor victory through the agency’s formal dispute resolution process; new drug application resubmission is targeted for first half of 2023.