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786,481 Results for "kinetix pharmaceuticals inc merged with amgen see amgen".
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Regulatory
Amgen’s Tavneos troubles continue as
NEJM
retracts pivotal publication
Earlier this year, Amgen refused the FDA’s request to withdraw Tavneos from the market. Now, two researchers who participated in the original study to support the drug’s approval claim they did not know the primary endpoint was readjudicated after the study was unblinded.
June 30, 2026
·
2 min read
·
Tristan Manalac
Podcast
Sentiment at BIO soars as FDA resets, dealmaking evolves; Amgen’s Tavneos in hot water
The vibe at BIO 2026 in San Diego last week was overwhelmingly positive, with attendees observing noticeable changes at the FDA and an uptick in dealmaking and IPOs. Plus, a top medical journal this week retracted a pivotal study for Amgen’s rare disease drug Tavneos, which has been in the FDA’s crosshairs since January.
July 1, 2026
·
2 min read
·
Jef Akst
Manufacturing
Amgen recalls almost 1 million bottles of heart failure drug over quality issue
The discovery of a foreign substance prompted Amgen to voluntarily recall batches of the medicine Corlanor made in Italy.
July 8, 2026
·
1 min read
·
Nick Paul Taylor
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
Rare diseases
Amgen shores up Tavneos’ FDA defense with Duke data analysis
After the FDA flagged patient deaths linked to Amgen’s rare disease drug Tavneos and called for its voluntary removal, the pharma recruited an independent data analysis from Duke researchers to help build the case for the drug’s continued market approval.
June 12, 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
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
·
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
·
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
·
2 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
·
2 min read
·
Tristan Manalac
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