US FDA’s novel agent count fell back to average as agency kept up high rate of complete response letters and refuse to file actions; CBER’s workload shifted to regenerative medicine.

Oncopeptides’ reversal on Pepaxto may or may not prove to be the right decision – but it underscores the inherent limits to US FDA’s efforts to police ‘dangling’ accelerated approvals.

After more review of clinical trial data, the myeloma drug’s sponsor wants to talk to the FDA again, but Oncopeptides execs said they cannot disclose the scientific details that led to the decision.

Gilead pulls Zydelig’s third-line indications in follicular B-cell lymphoma and small lymphocytic lymphoma due to confirmatory trial enrollment challenges resulting from an evolving treatment landscape; 13 cancer indications now have been withdrawn since the FDA began cracking down on accelerated approvals that have not confirmed clinical benefit.