FDA posts a 3/5 complete response letter to Rosemont Pharmaceuticals, rejecting the companys NDA for valacyclovir.
Senator Ron Johnson (R-WI) launches a congressional investigation into FDAs recent decisions to reject or delay treatments for rare diseases.
FDA launches its new Adverse Event Monitoring System to ultimately house all adverse events reported on FDA-regulated products on one searchable platf...
FDA approves Bristol Myers Squibs Sotyktu (deucravacitinib), an oral therapy for treating adults with active psoriatic arthritis.
A Newsweek report details four major issues it says have plagued FDA in its first year under commissioner Marty Makary.
FDA cites a U.K.-based clinical research center for failing to promptly report adverse events and for potential falsification of study records during ...
Vertex Pharmaceuticals says an interim analysis of its Phase 3 RAINIER trial showed its experimental therapy povetacicept significantly reduced protei...
FDA accepts for review a Capricor Therapeutics BLA resubmission for its experimental cell therapy deramiocel, intended to treat heart complications in...
