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Amgen

FDA stop sign
Manufacturing

FDA snubs Sobi’s gout drug over manufacturing issues

The FDA cited deficiencies at a contract manufacturing facility and is requiring additional data related to manufacturing control strategy.
Angus Liu Jun 29, 2026 11:04am
green light go go ahead advance yes streetlight

Viridian set for 1-on-1 vs. Amgen after FDA approval of Lumvoa

Jun 29, 2026 8:32am
European Union flag

Europe's CHMP reverses endorsement of Amgen's Tavneos

Jun 26, 2026 11:07am
Tavneos

Amgen to file 3rd-party review of Tavneos data for FDA hearing

Jun 12, 2026 11:12am
Amgen American Diabetes Association ADA ADA2026

ADA: Amgen talks Repatha, GLP-1 hurdles as obesity plan advances

Jun 7, 2026 9:13pm
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Tavneos patient starts resume in Japan amid safety scrutiny

May 21, 2026 11:38am

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