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.

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.

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

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 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 ...

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.

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 ...

An ongoing phase 2 trial is assessing the efficacy of elunetirom for adults with bipolar depression taking a mood stabilizer.

A second opinion physician was held liable for an unnecessary hysterectomy despite a laboratory mix-up at the original facility.

The NIAID evaluates treatment and prevention options for a wide range of diseases and conditions, which includes what research gets funded and which vaccines are developed. HealthDay News — Dr Jeffery ...