Novartis’ Ianalumab Granted FDA Breakthrough Therapy Designation for Sjögren’s Disease

The U.S. Food and Drug Administration has granted breakthrough therapy designation to ianalumab for Sjögren’s disease.

Human Trials Begin for Fentanyl Vaccine to Prevent Overdoses

A vaccine that blocks the effects of fentanyl, including overdoses, is scheduled for Phase I human trials in the Netherlands in early 2026 to assess its safety.

FDA Approves Expanded Label for Jascayd for PPF

Boehringer Ingelheim’s Jascayd (nerandomilast) has been given an expanded label by the U.S. Food and Drug Administration to include use in adults with progressive pulmonary fibrosis.

Lunsumio VELO Has Been Approved for R/R FL

FDA has approved CD20xCD3 bispecific Lunsumio VELO (mosunetuzumab), as a subcutaneous formulation, for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

FDA Approves First Gene Therapy Treatment for Wiskott-Aldrich Syndrome

The U.S. Food and Drug Administration has approved Waskyra (etuvetidigene autotemcel), the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome.

FDA Approves VOYXACT to Treat Kidney Disease

The U.S. Food and Drug Administration (FDA) has granted accelerated approval of VOYXACT (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. 

KEYTRUDA and KEYTRUDA QLEX Approved to Treat Adults Patients with MIBC

The U.S. Food and Drug Administration has approved KEYTRUDA and KEYTRUDA QLEX in combination with Padcev, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy.

Study Shows Hormone Therapy Is Linked to Autoimmune Disease

A recent study shows the use of hormone therapy in postmenopausal women was associated with a significantly higher incidence and risk of autoimmune diseases. 

FDA Accepts NDA for Leniolisib to Treat Children with APDS

FDA has accepted a supplemental new drug application for leniolisib to treat activated phosphoinositide 3-kinase delta syndrome, or APDS, in children aged 4 to 11 years.

FDA Approves Libtayo for Cutaneous Squamous Call Carcinoma

The U.S. Food and Drug Administration has approved Libtayo (cemiplimab-rwlc) for the adjuvant, or postsurgical, treatment of adults with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.