Findings showed both zanidatamab treatment arms demonstrated statistically significant and clinically meaningful improvements in PFS vs the SOC arm.

Immigration experts warn the policy could make it easier for officers to deny visas based on their own judgment.

The sNDA was supported by data from a 4 week MUSE study and a long-term open-label study in children aged 2 to 5 years.

The indication was restricted to only patients with DMD who are 4 years of age and older with a confirmed mutation in the DMD gene; the indication for non-ambulatory patients with DMD was removed.

Tyruko ® (natalizumab-sztn), a biosimilar to Tysabri ® (natalizumab), has been made available by Sandoz, according to developer Polpharma Biologics.