FDA approves Garzulys (insulin aspart-fsan) as a rapid-acting biosimilar to NovoLog for adult and pediatric patients with diabetes mellitus.
Elevated herpesvirus-directed responses and antiflagellin antibodies seen up to 10 years prediagnosis in Crohn disease ...
The sBLA is supported by phase 1b/2 OrigAMI-4 trial data demonstrating a 42% confirmed overall response rate in pretreated ...
A dose-escalation study in 24 healthy adults showed that an 810mL infusion produced results comparable to fresh frozen plasma without significant safety signals. The Food and Drug Administration (FDA) ...
Despite noting the high unmet need in Duchenne muscular dystrophy, the FDA panel concluded that trial data lacked substantial evidence of the therapy's effectiveness.
There was an increase in the proportion of exclusive GLP-1 RA use from 88.2% in May to November 2022 to 96.1% from June 2025 to January 2026. HealthDay News — Adolescents and young adults are ...
As number of risk factors increased, increase was seen in number of plaques and plaques with vulnerable phenotype.
Shionogi’s oral main protease inhibitor Xocova (ensitrelvir) is now available in the US to reduce the risk of symptomatic ...
PLEX100, an investigational prolonged-release local doxycycline product aimed at reducing surgical site infections in patients undergoing abdominal colorectal surgery.
Following an August 2025 CRL that raised no safety or manufacturing concerns, Saol provided additional survival analyses of existing clinical data to address FDA requirements without embarking on a ...
Cancer progression within 36 months of combination therapy identified patients with overall survival of less than 2 years.
HealthDay News — The 2026 American Heart Association/American College of Cardiology/multisociety guideline on the management of dyslipidemia has increased the US population recommended for primary ...