Japan’s decision gives quizartinib its first approval globally in specific first-line AML indication, in relatively small but high-need patient population.

The latest data from a Phase I/II study shows that pegtibatinase can yield a rapid, sustained reduction in homocysteine, the protein behind the underlying cause of the rare disease.

Allen Burton, the medical director of Abbott’s neuromodulation business and a leader in pain medicine, talked to Medtech Insight about the FDA’s new labeling for Abbott’s spinal cord stimulation devices that includes non-surgical back pain.

Mithra’s new CEO has immediately signaled a potential sale for the firm’s generics business as it looks to focus on branded assets in women’s health. Meanwhile, Sawai has reorganized its management team, the longtime chair of Viatris is moving on to another role, and a former AAM vice-president has joined Sandoz.