FDA Approves Imaavy for Warm Autoimmune Hemolytic Anemia

What Is Imaavy and How Does It Work? The FDA has approved Imaavy (nipocalimab-aahu) to treat adults and children 12 and older who have warm autoimmune hemolytic anemia (wAIHA). It is for people who are… Read more

FDA Approves Bixlenvo, a New Daily Pill to Treat HIV

The FDA has approved Bixlenvo for adults with HIV-1.It is meant for adults whose virus is already under control with their current HIV treatment. This means their blood test shows low levels of the virus,… Read more

FDA Approves Ziihera Combinations for Advanced Stomach and Esophageal Cancers

What Is Ziihera and How Does It Work? The FDA has approved Ziihera (zanidatamab-hrii) to treat adults with advanced or spreading gastroesophageal adenocarcinoma (GEA). GEA includes cancers of the stomach, the esophagus, and the area… Read more

FDA Approves Uplizna: A Twice-Yearly Targeted Therapy for Adults With Generalized Myasthenia Gravis

Uplizna (inebilizumab-cdon) is a prescription medicine recently approved by the FDA to treat adults with generalized myasthenia gravis (gMG) who test positive for certain antibodies — either anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase… Read more

Enhertu Plus Pertuzumab: New First-Line Option for Advanced HER2-Positive Metastatic Breast Cancer

Enhertu (fam-trastuzumab deruxtecan-nxki) is a type of targeted cancer treatment called an antibody-drug conjugate.The FDA has approved it in combination with another medicine, pertuzumab, as the first-line treatment for adults with HER2-positive breast cancer that… Read more

Enhertu Plus Pertuzumab: New First-Line Option for Advanced HER2-Positive Metastatic Breast Cancer

Enhertu (fam-trastuzumab deruxtecan-nxki) is a type of targeted cancer treatment called an antibody-drug conjugate.The FDA has approved it in combination with another medicine, pertuzumab, as the first-line treatment for adults with HER2-positive breast cancer that… Read more

FDA Approves Lerochol: A Monthly Injectable Treatment to Reduce High LDL Cholesterol Levels in Adults

Lerochol (lerodalcibep-liga) is a new medicine approved by the FDA to help lower elevated levels of low-density lipoprotein cholesterol (LDL-C), often called “bad cholesterol,” in adults with hypercholesterolemia (high cholesterol levels), including those with a… Read more

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