Tag Archives: approval

FDA Grants Accelerated Approval for Aduhelm (aducanumab-avwa) for the Treatment of Alzheimer’s Disease

FDA Grants Accelerated Approval for Aduhelm (aducanumab-avwa) for the Treatment of Alzheimer’s Disease CAMBRIDGE, Mass. and TOKYO, June 07, 2021 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Aduhelm™ (aducanumab-avwa) as the first and only Alzheimer’s… Read More »

Apervita’s NCQA approval helps health plans speed VBC analysis

Value-based care platform provider Apervita says it is the first company to be certified by the National Committee for Quality Assurance for electronic clinical quality measures using a clinical quality language-based engine. The company’s newly certified CQL-based engine—based on HL7 logic standards that support both eCQMs and clinical decision support—can be adopted by healthcare organizations… Read More »

Promising new sickle cell disease medicine wins FDA approval

This undated image provided by Novartis shows bottles of Novartis’s Adakveo. U.S. regulators have approved the new sickle cell disease medicine that can prevent extremely painful, dangerous “crises” in which misshapen blood cells clump together, reducing blood and oxygen flow. (Novartis via AP) After a recent decision by the FDA a better day could be… Read More »