Tag: FDA
FDA Unveils Initiative for Faster Biosimilar Development
The U.S. Food and Drug Administration (FDA) has unveiled a major initiative aimed at cutting both the time and cost required to develop biosimilar...
FDA Approves Omvoh by Eli Lilly for Ulcerative Colitis
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
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
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
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...
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