FDA schedules hearing on Concerta generic withdrawal as Ivonescimab secures first-line lung cancer indication in China

The U.S. Food and Drug Administration has granted a hearing to consider the withdrawal of a generic version of Concerta. The hearing will address regulatory concerns surrounding the product.

In China, the antibody drug Ivonescimab has been accepted for use as a first-line treatment for non-small cell lung cancer. The decision expands the therapeutic options available to patients in that market.

These developments highlight ongoing regulatory scrutiny in the United States and growing acceptance of new oncology therapies in Asia.