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 ...

HAIKOU, August 24. /TASS/. An innovative American drug Lumakras (also known as Sotorasib) for lung cancer and other types of cancer may soon become available at Hainan Lecheng Medical Cluster ...

Some are for existing medicines seeking label expansions, such as Lumakras and Amjevita, a rheumatoid arthritis medicine. Some are biosimilars for billion-dollar products that should lose patent ...

Sales of some key brands like Otezla and Lumakras are below expectations. However, revenues from key older medicines like ...

New data released by Merck suggests AstraZeneca and Sanofi’s Beyfortus, the monoclonal antibody injection that protects ...

Amgen’s Lumakras, in combination with antibody Vectibix, had shown an ORR of 27% in KRAS G12C mCRC before. In October 2023, Amgen announced a median, PFS of 5.6 months and 3.9 months with ...

Other products are Repatha, Blincyto, Parsabiv, Evenity, Aimovig, Lumakras/Lumykras, Kanjinti, Mvasi & Amgevita biosimilars.