Earlier this year, when the FDA asked Amgen to pull its rare disease drug Tavneos from the market, the California drugmaker ...
Amgen heads into Q1 earnings with growth from key drugs offset by pricing pressure, patent losses, and biosimilar competition.
The FDA has renewed calls for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence that study ...
The U.S. FDA announced on Tuesday that Amgen (AMGN) and AstraZeneca (AZN) have initiated real-time clinical trials as the agency seeks to launch a pilot program designed to accelerate drug development ...
Novartis, Amgen and Eli Lilly are betting that slashing levels of a particularly bad form of cholesterol could deliver the ...
The U.S. Food and Drug Administration's Center ​for Drug Evaluation ‌and Research on Monday proposed withdrawing approval of ...
Tavneos’ original developer hid a study analysis and then altered data, the FDA alleged. Elsewhere, Erasca’s RAS drug was met with skepticism and Rocket Pharma sold a voucher.
Statins cannot touch it. Neither can diet or exercise. Lipoprotein(a), a cholesterol-like particle hardwired into a person’s ...
The FDA today announced a new initiative to allow its reviewers to access information from clinical trials in real time, with ...
Amgen (AMGN) faces a U.S. withdrawal of its rare disease therapy Tavneos due to safety concerns and a potential manipulation ...
Amgen (NASDAQ:AMGN) today announced the retirement of David M. Reese, M.D., executive vice president and Chief Technology Officer, effective June 30, 2026.
Food and Drug ‌Administration's Center for Drug ‌Evaluation and Research on Monday ​proposed withdrawing approval of Amgen's ...