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Tag: FDA

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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...

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...

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Building the Right Team and Resource Model to Support Quality System and Validation Activities

Since life science quality and validation projects can vary...

Merck and Blackstone Enter R&D Funding Agreement for sac-TMT

Merck, recognized as MSD outside the U.S. and Canada,...

FDA Approves J&J’s DARZALEX FASPRO for HR-SMM in Adults

Johnson & Johnson said the U.S. Food and Drug...

FDA Approves UCB’s KYGEVVI for Thymidine Kinase 2 Deficiency

UCB, a leading global biopharmaceutical company, has announced that...

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