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.
FDA warns Dr. Daniel Goodman about objectionable conditions in a clinical trial at his San Francisco, CA-based Goodman Eye Center.
FDA publishes a guidance to help drug sponsors who are planning to conduct clinical studies in neonatal populations.
FDA issues a draft guidance to help ensure that information is available to patients and health care professionals to clearly communicate the benefits...