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Tag: America

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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...

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)....

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....

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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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