Waskyra: First Gene Therapy for Wiskott-Aldrich Syndrome

  Waskyra (etuvetidigene autotemcel) is a new gene therapy approved to treat Wiskott-Aldrich syndrome (WAS), a rare inherited condition that affects the immune system and blood cells.People with WAS often have frequent infections, easy bruising… Read more

FDA Approves Breyanzi: First and Only CAR T-Cell Therapy for Relapsed or Refractory Marginal Zone Lymphoma

  Breyanzi(lisocabtagene maraleucel) is a type of personalized cancer treatment called chimeric antigen receptor (CAR) T-cell therapy, which uses your modified T cells (white blood cells that help protect you from illness) to fight cancer.The FDA… Read more

Omisirge: A New Cell Therapy for Severe Aplastic Anemia and Blood Cancers

Omisirge (omidubicel-onlv) is a type of cell therapy made from umbilical cord blood.It helps your body make new blood cells after a stem cell transplant.What makes Omisirge different is that the cells are specially grown… Read more

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