Posts

Amgen Submits Extensive Data Package to FDA in Defense of Tavneos Approval

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Lumvoa emerges as strong Tepezza rival—but SC Tepezza looms on the horizon

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EU Regulators Recommend Revoking Marketing Authorization for Amgen's Tavneos

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FDA hearing on Amgen's Tavneos will include findings from an independent review

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Ethyreal Bio emerges with $101M to challenge Amgen’s Tepezza in thyroid eye disease

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AbbVie’s QULIPTA and Amgen’s Imdylltra Score New EU Approvals for Migraine and Lung Cancer Indications

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Amgen’s Tavneos, facing liver injury scrutiny, gets label update in Japan as patient starts resume

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Amgen Announces Additional $300M Investment in Puerto Rico Manufacturing Facility

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Amgen Abandons Cancer and Sjögren's Candidates Due to Weak Phase 2 Data

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FDA Announces Real-Time Clinical Trial Data Review Initiative with AstraZeneca and Amgen Pilots

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FDA Proposes to Withdraw Approval of Amgen's Tavneos Over Data Manipulation and Safety Issues

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FDA Ties Amgen's Tavneos to Eight Deaths and 76 Liver Injury Cases

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Amgen Rejects FDA Request to Withdraw Rare Disease Drug Tavneos

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Amgen Ends Autoimmune Alliance with Kyowa Kirin for Rocatinlimab Amid Safety and Efficacy Concerns

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Amgen Acquires Oxford Spinout Dark Blue Therapeutics for Up to $840 Million, Gaining Preclinical Cancer Drug

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FDA broadens label for Amgen’s Uplizna as it enters rare disease competition

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Amgen’s Repatha Reduces First-Time Cardiovascular Events by 25% in Major Clinical Trial

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Amgen Builds Case for Repatha to Prevent Heart Disease With Landmark Late-Stage Data

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Despite Government Shutdown, Companies Still Plan to Submit FDA Applications

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Amgen's Repatha Cholesterol-Lowering Shot Poised for Sales Boost After Landmark CV Prevention Trial Success

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