--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 ...

Amgen also has several Phase 1b studies investigating sotorasib monotherapy and sotorasib combination therapy across various advanced solid tumors (CodeBreaK 101) open for enrollment. xix A Phase ...

Amgen also has several Phase 1b studies investigating sotorasib monotherapy and sotorasib combination therapy across various advanced solid tumors (CodeBreaK 101) open for enrollment. 12 A Phase 2 ...

Amgen also has several Phase 1b studies investigating sotorasib monotherapy and sotorasib combination therapy across various advanced solid tumors (CodeBreaK 101) open for enrollment. xix A Phase ...

McCarthy said the FDA was prohibited by law from discussing the particulars of its sotorasib regulation plans. Switching to a 240-mg dosage could register a huge hit to Amgen’s revenue.

The initiative, Project Optimus, launched in 2021 just as Amgen was seeking to market sotorasib. At the time, the FDA’s leading cancer drug regulator, Richard Pazdur, co-authored an editorial in ...

Amgen is progressing the largest and broadest global KRAS G12C inhibitor development program with unparalleled speed and exploring more than 10 sotorasib combination regimens, with clinical trial ...

Ratain, a staunch critic of Amgen's handling of sotorasib, told Centers for Medicare & Medicaid Services officials at a recent meeting that they should pay for sotorasib on a basis of 240 mg per day.

Amgen also has several Phase 1b studies investigating sotorasib in combination with several other treatments across various advanced solid tumors (CodeBreaK 101) open for enrollment. 12 A Phase 3 ...

Amgen Announces New LUMAKRAS™ (sotorasib) Combination Data From Phase 1b CodeBreaK 101 Study In Patients With KRAS G12C-mutated Cancers At AACR-NCI-EORTC 2021 Published Oct 7, 2021 9:00am EDT ...