Amgen today announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) will review data supporting the supplemental New Drug Application (sNDA) for the full approval of LUMAKRAS® (sotorasib) for adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC) at a meeting on Oct. 5, 2023.
Agomab wins FDA orphan drug status for idiopathic pulmonary fibrosis asset – Pharmaceutical Technology
Agomab is now eligible for market exclusivity and a range of financial incentives. Image credit: Shutterstock / HammadKhn. Six months after kicking off a Phase