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FDA launches a new Web page for clinical lab staff and healthcare providers on the impact of viral mutations on Covid-19 tests.[ Price : $8.95]
CDRH says it will hold a two-day meeting of its Medical Devices Advisory Committees Circulatory System Devices Panel to review inf...[ Price : $8.95]
FDA accepts for priority review a Mirum Pharmaceuticals NDA for maralixibat, an oral apical sodium dependent bile acid transporter...[ Price : $8.95]
FDA approves a Celgene BLA for Abecma (idecabtagene vicleucel), a cell-based gene therapy for treating certain adult patients with...[ Price : $8.95]
FDA approves an Astellas Pharma NDA for Myrbetriq (mirabegron extended-release tablets) for treating neurogenic detrusor overactiv...[ Price : $8.95]
FDA grants a de novo marketing authorization for Helius Medicals Portable Neuromodulation Stimulator, indicated for use as a short...[ Price : $8.95]
FDA sends Merck a complete response letter on a supplemental BLA for Keytruda, the companys anti-PD-1 therapy for treating certain...[ Price : $8.95]
CDER says a recently published meta-analysis of progestogen use to reduce pre-term birth risk is not persuasive and will not chang...