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779,980 Results for "kinetix pharmaceuticals inc merged with amgen see amgen".
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Regulatory
FDA alleges ‘manipulated’ data supported approval of Amgen’s autoimmune drug
The FDA has renewed calls for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence that study personnel doctored the results of the drug’s pivotal study in order to make it look effective.
April 28, 2026
·
2 min read
·
Tristan Manalac
Immunology and inflammation
Amgen Seeks ‘Return to Growth’ for Tepezza as More Convenient Formulation Aces Phase 3
Sales of Amgen’s thyroid eye disease drug Tepezza have slowed, dipping 1% to $457 million in the fourth quarter of 2025.
April 7, 2026
·
3 min read
·
Tristan Manalac
Regulatory
FDA Ties Amgen’s Rare Inflammatory Disease Drug to Eight Deaths, Dozens of Liver Injuries
The FDA in January asked Amgen to pull Tavneos from the market, citing liver toxicity issues that affected the drug’s overall risk-benefit profile. The pharma refused.
April 1, 2026
·
2 min read
·
Tristan Manalac
Rare diseases
Amgen Will Not Heed FDA Request To Withdraw Rare Disease Drug Tavneos
After review, Amgen is certain that Tavneos is effective and has a favorable benefit-risk profile. The company informed the FDA on January 28 that they would not pull the drug.
February 4, 2026
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2 min read
·
Annalee Armstrong
Manufacturing
How North Carolina Attracted Amgen and Roche To Become a Next-Gen Obesity Drug Production Hotspot
Infrastructure and location have helped make Holly Springs a future hub for obesity drug production, with Amgen and Roche planning to manufacture GLP-1 therapies there to compete in the growing market.
March 3, 2026
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4 min read
·
Nick Paul Taylor
Earnings
Amgen Wants MariTide To Change Obesity Paradigm With Longer Dosing Periods
Amgen believes that it can transcend the expected tradeoff between convenience and efficacy, anticipating that its investigational obesity drug MariTide will continue to provide competitive weight loss even at monthly or longer schedules.
February 4, 2026
·
2 min read
·
Tristan Manalac
Regulatory
FDA Action Alert: BMS, GSK, Amgen and More
The FDA’s docket in December includes decisions for two big biologic franchises: BMS’s Breyanzi and Amgen’s Uplizna.
December 1, 2025
·
5 min read
·
Tristan Manalac
Autoimmune disease
Amgen Ends Autoimmune Alliance With Kyowa Kirin Amid Safety, Efficacy Questions
A Phase III readout in September 2024 for rocatinlimab, on which Amgen and Kyowa Kirin were collaborating in atopic dermatitis, appeared underwhelming to analysts, with Jefferies noting that the data “came in at the lower end of efficacy and expectations.”
February 2, 2026
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2 min read
·
Tristan Manalac
Cardiovascular disease
Amgen’s Repatha Cuts Risk of First Heart Attack by 36% in Phase III Trial
The cholesterol-lowering drug is part of a suite of medicines that also includes MariTide and that Amgen Chief Medical Officer Paul Burton hopes will make the company the “undisputed leader in the management of cardiometabolic risk for patients” by 2030.
November 10, 2025
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4 min read
·
Heather McKenzie
Immunology and inflammation
Zenas Plummets After Late-Stage Data Fall Short of Amgen in Inflammatory Disease
While Zenas’ obexelimab hit the primary endpoint in the Phase III INDIGO study, it came far below the efficacy threshold set by Amgen’s B cell depleter Uplizna, approved by the FDA for IgG4-related disease last April.
January 6, 2026
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2 min read
·
Tristan Manalac
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