The study demonstrated a favorable safety profile, with the consolidated single-infusion regimen showing fewer infusion reactions compared to the reference regimen.

Phase 3 data support a lower age threshold for linaclotide, making it the first prescription therapy approved for functional constipation in patients ages 2 to 5.

The Agency will review supplemental data from AstraZeneca to address ODAC concerns regarding overall survival benefit, trial design interpretation, and cardiovascular safety.

Investigational oral substrate therapy BBP-418 demonstrated significant increases in alpha-dystroglycan glycosylation and improved ambulatory function in the phase 3 FORTIFY interim analysis.

The Trump administration has issued a directive shutting key US health research officials out of global discussions on virus outbreaks, according to CNN. Specifically, officials from the National ...