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10,545 Results for "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
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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
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3 min read
·
Tristan Manalac
Manufacturing
Amgen, Sanofi commit nearly $600M to North American expansions
Sanofi’s investment will support a Canadian site’s efforts to apply AI to drug production, while Amgen has unveiled the second expansion of its Puerto Rico plant in quick succession.
May 6, 2026
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2 min read
·
Nick Paul Taylor
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
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2 min read
·
Tristan Manalac
Postmarket research
Update: Reversal after 20 deaths allows new Japan patients to take Amgen’s rare disease drug Tavneos
Kissei Pharmaceutical is reversing a recommendation related to Amgen-shared Tavneos that it made just a few days ago, now saying the rare disease drug can be given to new patients.
May 21, 2026
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3 min read
·
Tristan Manalac
Earnings
Amgen positions MariTide as potential ‘best monthly’ obesity drug
Amgen has launched a late-stage program to test the feasibility of switching patients from weekly GLP-1 injections to its own investigational obesity asset MariTide, which could open up monthly or more infrequent dosing schedules.
May 1, 2026
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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
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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
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5 min read
·
Tristan Manalac
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