FDA sends Novartis Pharmaceuticals an untitled letter citing the companys allegedly false or misleading direct-to-consumer television advertisement fo...
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...
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...
Hansa Biopharma says imlifidase met the primary endpoint in a pivotal Phase 3 study in kidney transplant patients.
FDA publishes a guide to its Electronic Submission Gateway NextGen Unified Submission Portal.
