Following a manufacturing-related Complete Response Letter in June 2026, the resubmitted application for the once-monthly subcutaneous depot is back under FDA review.

The transition from accelerated to traditional approval is backed by robust 24-month eGFR data from the phase 3 APPLAUSE-IgAN trial.

Shionogi’s application seeks approval for pediatric patients (from 26 weeks gestational age to under 18 years) based on data from 154 patients across three phase 2 trials.

Most ION events occurred in men, patients 50 years or older, with minimal risk seen in women, patients younger than 50 years ...

Clinicians should maintain a high index of suspicion for Cyclospora in patients presenting with prolonged or relapsing watery diarrhea this summer.

FDA clears subcutaneous Sarclisa Escena for multiple myeloma, showing comparable overall response rates to IV delivery.

By neutralizing circulating dipeptidyl peptidase 3, the novel monoclonal antibody aims to reverse RAAS dysregulation and stabilize cardiovascular hemodynamics.

Supported by phase 3 SYMPHONY and ENCORE trial data, AXS-12 significantly reduced weekly cataplexy attacks and improved daytime sleepiness and cognition.

At 12 months, adults with insulin-treated diabetes had significant improvements in HbA1c and hospitalizations.

Targeting effective control of rheumatoid arthritis disease activity is crucial component of treatment strategy.

A considerable proportion of adolescents are not aware of the dangers of fentanyl use, according to a study published online ...

Higher vitamin A is associated with better lung function in children and adults, while vitamin D levels are associated with lower epigenetic aging in asthma in ...