CDER says a recently published meta-analysis of progestogen use to reduce pre-term birth risk is not persuasive and will not change its course to with...
FDA accepts for priority review a Mirum Pharmaceuticals NDA for maralixibat, an oral apical sodium dependent bile acid transporter inhibitor for treat...
FDA approves a Celgene BLA for Abecma (idecabtagene vicleucel), a cell-based gene therapy for treating certain adult patients with multiple myeloma.
FDA approves an Astellas Pharma NDA for Myrbetriq (mirabegron extended-release tablets) for treating neurogenic detrusor overactivity in pediatric pat...
FDA grants a de novo marketing authorization for Helius Medicals Portable Neuromodulation Stimulator, indicated for use as a short-term treatment for ...
FDA sends Merck a complete response letter on a supplemental BLA for Keytruda, the companys anti-PD-1 therapy for treating certain patients with high-...
FDA Review posts the Federal Register notices for the week ending 3/26/2021.
CDRH officials reflecting on Covid-19 experience say at-home diagnostics will accelerate technological advances that benefit routine medical care and ...