Bristol Myers’ KRAS Confirmatory Data Avoid Amgen’s Flaws but Leave FDA Prospect Unclear

Bristol Myers Squibb, KRAS confirmatory data, Amgen, FDA, accelerated approval pathway, oncology therapies, clinical benefits, confirmatory trials

FDA Approves Amgen’s Bkemv, First Interchangeable Biosimilar to Soliris for Rare Blood Disorders ###

Bkemv, Soliris, FDA approval, Interchangeable biosimilar, Rare blood disorders, Paroxysmal nocturnal hemoglobinuria (PNH), Atypical hemolytic uremic syndrome (aHUS), Amgen, AstraZeneca, Alexion Pharmaceuticals

Amgen Secures FDA Approval for Bkemv, the First Interchangeable Biosimilar to Soliris for Rare Blood Disorders

FDA approval, Amgen, Bkemv, Soliris, biosimilar, rare blood disorders, paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS)

FDA Greenlights Amgen’s Innovative T Cell Therapy for Aggressive Lung Cancer

FDA, Amgen, T cell engager, lung cancer, aggressive, AMG 757, bi-specific T cell engager, small cell lung cancer, immunotherapy, cancer treatment, clinical trials.

Sandoz Wins Historic FDA Approval for First Two Interchangeable Denosumab Biosimilars Targeting Amgen’s Blockbuster Bone Therapy

Sandoz, FDA approval, Denosumab biosimilars, Wyost, Jubbonti, Interchangeable, Prolia, Xgeva, Amgen, Osteoporosis, Bone metastases, Cancer-related skeletal events, Patent litigation