Tag: FDA

U.S Food and Drug Administration (FDA)

FDA Grants Accelerated Approval to Gilead’s Livdelzi for PBC

FOSTER CITY, Calif : Gilead Sciences recently announced that the U.S. Food…

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Novartis’ Fabhalta gets FDA nod for IgAN Treatment

Basel- August 2024- Novartis announced that the U.S. Food and Drug Administration…

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Is This the Future of Afib Treatment? Mayo Clinic’s Answer

Rochester- July 2024- Cardiologists in Mayo Clinic's Heart Rhythm Clinic are using…

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Tempus’ xT CDx Achieves Breakthrough Designation as First ADLT for Tumor Mutation Profiling

July 2024- Tempus announced that the Centers for Medicare & Medicaid Services…

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Good News! Roche granted FDA Breakthrough Device Designation for blood test measuring Lp(a)

Basel- 22 May 2024 - Roche announced that the Tina-quant® lipoprotein Lp(a)…

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Lilly Statement on FDA Advisory Committee Meeting on Donanemab

May 2024- The U.S. Food and Drug Administration (FDA) will convene an…

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Latest CAVT Technology Designed to Remove Blood Clots

April 2024- Penumbra announced the U.S. Food and Drug Administration (FDA) clearance…

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Abbott’s Breakthrough Dissolving Stent Receives FDA Approval

May 2024- Abbott announced that the U.S. Food and Drug Administration (FDA)…

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U.S. FDA Approves Subcutaneous Administration of Takeda’s ENTYVIO® (vedolizumab)

Osaka, Japan- April 2024- Takeda announced that the U.S. Food and Drug…

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FDA approves Alecensa as first adjuvant treatment for people with ALK-positive early-stage lung cancer

Basel- April 2024- Roche announced that the U.S. Food and Drug Administration…

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