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FDA Approvals

FDA Approves Omvoh by Eli Lilly for Ulcerative Colitis

Americas
Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has approved a new single-injection, once-monthly maintenance option (200 mg/2...

FDA Approves Novo Nordisk’s Rybelsus Oral GLP-1 Therapy

Americas
Novo Nordisk has announced that the US Food and Drug Administration (FDA) has granted approval for Rybelsus®, the only oral GLP-1 therapy, to reduce...

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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The Future of Digital Health

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The pharmaceutical industry is acutely aware that the future of health and care, particularly in the United States, are trending toward a digital revolution....

Five Best Practices to Deliver Exceptional Multichannel Experiences

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A one-size-fits-all customer journey no longer works. In the age of the consumer, the quality of the interaction is paramount. In this paper, we...

The Impact and Use of Social Media in Pharmacovigilance

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Social media presents new channels and methods for biopharmaceutical companies to move away from traditional pharmacovigilance (PV) systems and safety reporting methods towards more...

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