Tag: FDA
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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...
US FDA Launches Fast-Track Review Scheme for Generic Drugs
The FDA has introduced a pilot fast-track review programme aimed at accelerating reviews for generic medicines tested and manufactured within the United States, marking...
