CDER director George Tidmarsh urges more compliance with clinical trial reporting requirements through the Clinicaltrials.gov gateway.
AbbVie files an NDA for tavapadon, an investigational once-daily oral therapy for Parkinsons disease.
FDA grants Essilor a de novo marketing authorization for its Stellest eyeglass lenses, which are designed to both correct vision and slow the progress...
FDA approves a Crinetics NDA for Palsonify (paltusotine) for treating adults with acromegaly who have had an inadequate response to surgery and/or for...
FDA sends Novartis Pharmaceuticals an untitled letter citing the companys allegedly false or misleading direct-to-consumer television advertisement fo...
HHS secretary Robert F. Kennedy, Jr., says FDA is reviewing safety evidence relating to the medication abortion drug mifepristone.
FDA says the Risk Evaluation and Management Strategy program that has been in place since 2011 for Sanofis thyroid cancer drug Caprelsa is no longer n...
Capricor Therapeutics reaches agreement with FDA on the design and role of its HOPE-3 trial as it works to resubmit its BLA for Deramiocel and its use...
