The FDA was expected to decide on the application of sotorasib and panitumumab for the treatment of metastatic colorectal ...

The regulator has delayed its respective decision dates on whether to grant full approval to Amgen’s Lumakras in metastatic ...

The FDA is looking at four events for the remainder of October, one of which is an advisory committee meeting for a dual SGLT ...

Lumakras was cleared by the FDA in May 2021 for KRAS G12C-mutated NSCLC patients who have received at least one prior systemic therapy, marking the culmination of a decades-long effort to bring a ...

Amgen has made progress with its plans to expand the use of its first-in-class KRAS inhibitor Lumakras, reporting encouraging results when the drug is used alongside its EGFR drug Vectibix in ...

Amgen will need to run another confirmatory study to win full FDA approval of its lung-cancer drug Lumakras. Amgen says the FDA, which granted conditional approval to the drug in 2021, has turned ...

Some of its most recent brand-new launches, especially the cancer drug Lumakras, have made paltry (at best) contributions to its top line, while some of its legacy products are racking up ...