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

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

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

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 ...

LUMAKRAS, and the newly launched IMDELLTRA. The rare diseases segment also did well. This segment enjoyed a bigger focus after Amgen acquired Horizon Therapeutics. In 2Q24, it achieved more than $ ...

Krazati has been cleared as a treatment for patients with KRASG12C-mutated non-small cell lung cancer (NSCLC) after one prior systemic therapy – the same indication given to Amgen's Lumakras ...

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 ...

Recent launches include Repatha (cholesterol-lowering), Aimovig (migraine), Lumakras (lung cancer), and Tezspire (asthma). The 2023 Horizon acquisition brings several rare-disease drugs ...

Recent launches include Repatha (cholesterol-lowering), Aimovig (migraine), Lumakras (lung cancer), and Tezspire (asthma). The 2023 Horizon acquisition brings several rare-disease drugs ...

Both Lumakras and Krazati had been FDA-approved as second-line therapies for KRAS G12C-mutated non-small cell lung cancer (NSCLC) – in 2021 and 2022, respectively – and marked the culmination ...

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 ...