Voyxact: FDA Grants Accelerated Approval to Once-Monthly Injection for Adults With IgA Nephropathy

Voyxact (sibeprenlimab-szsi) is a new medicine approved by the FDA to lower protein levels in urine for adults with a kidney condition called primary immunoglobulin A nephropathy (IgAN) who are at risk of their illness… Read more

Itvisma: FDA Approves One-Time Gene Therapy for Spinal Muscular Atrophy in Children 2 or Older, Teens, and Adults

Itvisma (onasemnogene abeparvovec-brve) is a gene therapy that the FDA has approved to treat spinal muscular atrophy (SMA) in adults, teens, and children 2 or older who have a confirmed mutation in the survival motor… Read more

Hyrnuo: New Oral Treatment for Advanced HER2-Mutant Lung Cancer

Hyrnuo (sevabertinib) is a new oral medicine for adults with advanced nonsquamous non-small-cell lung cancer (NSCLC) carrying a specific genetic change known as HER2 (ERBB2) TKD activating mutations and whose cancer has either advanced locally… Read more

Keytruda and Padcev: FDA Approves New Combination Therapy for Aggressive Bladder Cancer

The FDA has approved a new combination therapy that uses two different types of anticancer medicines for treating adults with muscle-invasive bladder cancer (MIBC) who can’t receive cisplatin, a common chemotherapy drug.The approved combination includes… Read more

Cavhanza (Nilotinib): FDA Approves Orally Disintegrating Tablet for Adults With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia

Cavhanza (nilotinib) is a new FDA-approved orally disintegrating tablet (ODT) formulation of nilotinib, a prescription medicine used to treat a type of blood cancer called Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).The FDA has approved… Read more

Hympavzi: Once‑Weekly, Single‑Dose Under‑the‑Skin Shot to Help Prevent Bleeding in Hemophilia A or B (ages 6+)

Hympavzi (marstacimab‑hncq) is a preventive medicine you take as a once‑weekly shot under the skin.It is used in adults and in children 6 and older with hemophilia A or hemophilia B, whether or not you… Read more

Parsol Shield: FDA Approves New Sunscreen Active Ingredient for Broad UV Protection

Bemotrizinol is a sunscreen active ingredient that helps protect your skin from ultraviolet A (UVA) and ultraviolet B (UVB) rays.Parsol Shield is expected to be the first sunscreen available with this ingredient.The FDA has determined… Read more

FDA Approves Redemplo to Lower Triglycerides

Redemplo (plozasiran) is a type of medicine called a small interfering RNA (siRNA) therapy approved to help lower extremely high triglyceride levels in adults with familial chylomicronemia syndrome (FCS) or ongoing chylomicronemia.This medicine works by… Read more

FDA Approves Tzield to Slow the Decline of Natural Insulin Production in People 8-17 Years Old With Newly Diagnosed Stage 3 Type 1 Diabetes

Tzield (teplizumab-mzwv) is a prescription immune therapy that can help delay the progression of type 1 diabetes (T1D). The FDA has approved Tzield for slowing the decline of natural insulin production in children aged 8-17… Read more

FDA Approves Truqap as the First Targeted Therapy for PTEN-Deficient Metastatic Prostate Cancer

Truqap (capivasertib) is an oral targeted cancer medicine. The FDA has now approved it to be used together with abiraterone and prednisone for a specific type of advanced prostate cancer. It applies to adults whose… Read more