The 3-month extension follows a major amendment to the NDA for the intrathecal cyclodextrin-based therapy, which has shown a 71% reduction in mortality risk in clinical trials.

The combination regimen significantly improved progression-free survival and objective response rates in patients who were intolerant to or failed prior imatinib therapy ...

Backed by the phase 2b/3 EPICS-III trial, saroglitazar demonstrated a significant 56.7% biochemical response rate compared with 9.8% for placebo, while showing favorable safety data.

Guselkumab was associated with significant inhibition of structural joint damage in adults with active psoriatic arthritis. The Food and Drug Administration (FDA) has approved updated labeling for ...

Researchers found that the ferritin curve inflection for ID occurred at 23.9µg/L with hemoglobin and 25.0µg/L with erythrocyte zinc protoporphyrin. HealthDay News — Physiologically based ferritin ...

ACS emphasizes that offering multiple, recommended screening options supports informed patient choice and may improve participation. HealthDay News — In an update to the American Cancer Society (ACS) ...

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

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

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 ...

Candin achieved a 45.4% durable clearance rate for the treated wart, nearly doubling the 23.4% clearance rate observed in the placebo group. Topline data were announced from a completed phase 3 trial ...