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Tag: FDA

FDA Approves Celltrion’s EYDENZELT for Retinal Diseases

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

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

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...

US FDA Approves Jascayd for Idiopathic Pulmonary Fibrosis

The U.S. Food and Drug Administration (FDA) has approved Jascayd (nerandomilast) tablets to treat idiopathic pulmonary fibrosis (IPF), a rare and serious lung disease....

FDA Clears Tissue Repair Drug AD-NP1 For Clinical Trials

The FDA has granted approval to begin clinical trials of the AD-NP1 drug. It is a first-in-class drug for tissue regeneration, which targets cellular...

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