Federal Register notice: FDA sets fee rates and payment procedures for fiscal year 2023 for animal drug user fees.
An AP report says FDA commissioner Robert Califf is facing skepticism that the agency will address the nations opioid crisis in a meaningful way.
FDA reviews the first-year accomplishments and future plans for the multi-country Generic Drug Cluster.
Researchers in the U.S. and Australia call for an update to transparency policies so that all individual participant data supporting oncology drug reg...
FDA sets 5/23/23 as the target PDUFA action date for its review of ImmunityBios N-803 to treat some bladder cancers.
FDA accepts for review a Lexicon Pharmaceuticals NDA resubmission for sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor for treating he...
Senate leaders introduce the Cannabis Administration and Opportunity Act.
FDA grants breakthrough therapy designation to Vertex VX-548 for some acute and neuropathic pain indications.
