Amgen is under significant pressure as the FDA raises concerns over liver injury cases and fatalities associated with its rare disease drug, Tavneos. This scrutiny threatens to overshadow the company's ambitions in the oncology market, supported by partnerships like its collaboration with Zai Lab and the development of new products such as the weight loss drug MariTide. While Amgen forecasts strong revenue growth, challenges from pricing pressures and soon-to-launch biosimilars for key drugs like Prolia and Xgeva loom large over its financial outlook.

“US FDA warns of liver injury cases tied to Amgen’s rare disease drug.”

“Amgen's Tavneos under fresh scrutiny after FDA flags liver injury deaths $AMGN”

“FDA Says Amgen’s Tavneos Linked to Liver Injuries, Deaths https://t.co/hPmhJgBQ6b”

“FDA Says Amgen’s Tavneos Linked to Liver Injuries, Deaths”

“US FDA warns of liver injury cases tied to Amgen’s rare disease drug.”

“Tarlatamab (Imdelltra) by Amgen in Thousand Oaks, CA - for extensive-stage SCLC.”

“The FDA links Amgen's Tavneos (avacopan) to liver injuries and eight deaths, with 76 cases of drug-induced liver injuries (DILI), including 54 hospitalizations.”
“Meanwhile, Amgen is developing new medicines such as MariTide, an investigational GLP-1 therapy currently in phase 3 trials. MariTide could be Amgen's way of cashing in on the vast and growing weight loss market.”