Amgen’s Lumakras became the first FDA-approved drug that addresses the elusive KRAS mutation, but Mirati believes its newly approved therapy, Krazati, could be better. The small molecule’s ...

--Amgen announced today that the U.S. Food and Drug Administration has completed its review of the company's supplemental New Drug Application seeking full approval of LUMAKRAS ®. About Advanced ...

THOUSAND OAKS, Calif., Aug. 21, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) will review data ...

At issue is a trial that Amgen is relying upon to win final approval for Lumakras, which the FDA approved on a conditional basis in 2021. This process, known as accelerated approval, required the ...

Buoying Amgen’s commitment to Lumakras—and the 960-mg dose—are new phase 3 data presented Sunday at the European Society of Medical Oncology Congress detailing the drug in combination with ...

A U.S. lawmaker is accusing Amgen of “putting profits before patients” over its decision to continue marketing a high dose of a pricey cancer treatment.

THOUSAND OAKS, Calif., Sept. 10, 2023 /PRNewswire/ -- Amgen (AMGN) today announced exciting data from a study arm of the CodeBreaK 101 clinical trial, a Phase 1b study evaluating LUMAKRAS ...

The FDA released briefing documents ahead of Oncologic Drugs Advisory Committee meeting scheduled for October 5 to review Amgen Inc's AMGN supplemental application for complete approval of ...

Amgen Inc. said it would continue to work closely with the Food and Drug Administration to seek full approval for its Lumakras cancer drug as a treatment for a form of lung cancer, after an ...

LUMAKRAS ® (sotorasib) Demonstrated Delayed Time to CNS Progression, Longer CNS PFS and Higher Intracranial ORR vs Docetaxel in Post-Hoc Analysis of Phase 3 CodeBreaK 200 Trial LUMAKRAS Shows ...

Amgen’s AMGN stock has risen 21.7% so far this year compared with an increase of 7% for the industry. ... Repatha, Lumakras, Tezspire, Uplizna and Blincyto for additional indications.