AstraZeneca recently announced that the FDA granted accelerated approval to camizestrant (Etcamah) in combination with a CDK4/6 inhibitor for adults with HR-positive/HER2-negative locally advanced or metastatic breast cancer. The indication applies when an ESR1 mutation is detected during first-line aromatase inhibitor plus CDK4/6 inhibitor therapy using an FDA-authorized test. Approval Highlights SERENA-6 reduced the risk […]
Johnson & Johnson announced on August 24 that the FDA approved IMAAVY (nipocalimab-aahu) for warm autoimmune hemolytic anemia (wAIHA) in patients aged 12 and older previously or currently treated with corticosteroids. It is the first FDA-approved treatment for wAIHA. The approval adds the first treatment option for this rare blood disorder and marks the expansion […]