Approval is supported by phase 3 INShore trial data demonstrating 95% sustained complete remission at 52 weeks with obinutuzumab compared with 73% with MMF.

The intravenous immune globulin replacement therapy is currently being evaluated in a phase 3 clinical trial assessing motor function and mobility in adult patients with stiff person syndrome.

The FDA has accepted and granted Priority Review to an application for lower doses of leniolisib to treat younger children with activated phosphoinositide 3-kinase delta syndrome.

HealthDay News — Nutritional deficiencies are a common and underrecognized risk among pediatric patients receiving glucagon-like peptide-1 receptor agonist (GLP-1 RA) treatment, according to a study ...

Routine FDA testing found patulin above safety limits in Wholesome Pantry jars sold at ShopRite and four other chains ...

The FDA approved Bravnetsa as the first radioligand therapy through the Abbreviated New Drug Application pathway, offering a bioequivalent alternative to Lutathera for adult patients with ...

Lyrfigtu (lirafugratinib) is approved for previously treated, unresectable, or metastatic FGFR2-altered cholangiocarcinoma based on data from the ReFocus trial.

HealthDay News — For patients receiving immune checkpoint inhibitors (ICIs), rheumatic immune-related adverse events (rh-irAEs) are usually moderate or severe, with more than one-third leading to ...

Eleven-point-four percent of patients who underwent liver transplantation for cirrhosis developed cirrhosis subsequent to transplant.

In the phase 3 OASIZ 301 trial, the investigational drug dazodalibep significantly reduced systemic disease activity in patients with moderate to severe Sjögren disease compared with placebo.

The investigational mannose-1-phosphate replacement therapy aims to restore metabolic function and improve neurological outcomes in pediatric and adult patients.

Monthly subcutaneous sefaxersen significantly reduced proteinuria compared with placebo at week 37 in patients with primary IgA nephropathy at high risk of disease progression.