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ACHEMA MIDDLE EAST 2026
5th LNP Formulation & Process Development Summit

Tag: FDA

FDA Approves Amgen and AstraZeneca’s TEZSPIRE for CRSwNP

Americas
Amgen and AstraZeneca have announced that the U.S. Food and Drug Administration (FDA) has granted approval for TEZSPIRE® (tezepelumab-ekko) as an add-on maintenance therapy...

FDA Clears Genentech’s Gazyva for Lupus Nephritis in Adults

Americas
Genentech, part of the Roche Group, has announced that the U.S. Food and Drug Administration (FDA) has approved Gazyva® (obinutuzumab) for adults with active...

FDA Approves Celltrion’s EYDENZELT for Retinal Diseases

Americas
Celltrion, Inc. said the U.S. Food and Drug Administration (FDA) has approved EYDENZELT® (aflibercept-boav), a biosimilar of EYLEA® (aflibercept), for several retinal conditions. These...

FDA Clears UZEDY Injection for Bipolar I Disorder in Adults

Americas
The U.S. Food and Drug Administration (FDA) has approved UZEDY® (risperidone) as a once-monthly, extended-release injectable suspension for adults with bipolar I disorder (BD-I)....

FDA Clears Elecsys pTau181 Alzheimer’s Test by Roche, Lilly

Americas
The US Food and Drug Administration (FDA) has approved a new blood test aimed at assessing Alzheimer’s disease and other cognitive impairments, potentially allowing...
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