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FDA grants breakthrough device designation for the Roche Elecsys Amyloid Plasma Panel that detects and measures Alzheimers disease...[ Price : $8.95]
FDA accepts for priority review an Apellis Pharmaceuticals NDA for intravitreal pegcetacoplan, an investigational, targeted C3 the...[ Price : $8.95]
The Alliance for Natural Health calls on FDA to require a Boxed Warning for proton pump inhibitors on the risk of dementia associa...[ Price : $8.95]
FDA adds two updates to its Web page FAQs on Supplies of Medical Devices for Covid-19.[ Price : $8.95]
FDA grants de novo marketing authorizations for Apollo Endosurgery and its Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REV...[ Price : $8.95]
The U.S. CDC Advisory Committee on Immunization Practices votes unanimously to recommend the use of the Novavax Covid-19 Vaccine, ...[ Price : $8.95]
CDRH seeks feedback on its new eSTAR and eCopy electronic submission process for 510(k) and De Novo device submissions.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance #100 entitled Impurities: Residual Solvents in New Veterinary Medici...