Novo Nordisk refiles its BLA for Awiqli (insulin icodec), a once-weekly basal insulin injection for adults with Type 2 diabetes.
FDA tells IO Biotech not to submit a BLA for its experimental cancer vaccine Cylembio based on results from a recently completed Phase 3 trial in adva...
FDA expands its medical device Early Alert program to cover all products that may pose significant safety risks.
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...
