Ocaliva Pulled From U.S. Market for Liver Disease

Ocaliva (obeticholic acid) is a medicine used to treat a rare liver condition called primary biliary cholangitis (PBC). On Sept. 11, 2025, Intercept Pharmaceuticals announced the voluntary withdrawal of Ocaliva from the U.S. market following… Read more

FDA Approves Enbumyst: First and Only Nasal Spray Diuretic for Edema From Heart, Liver, and Kidney Diseases

Enbumyst is a new nasal spray form of bumetanide (first approved by the FDA in 1983). It is a type of medicine called a loop diuretic (also known as a “water pill”), which helps your… Read more

Gazyva: FDA Approves Antibody-Based Infusion Therapy for Adults With Lupus Nephritis

Gazyva (obinutuzumab) is a lab-made antibody medication used for treating certain blood cancers. The FDA recently approved the combined use of Gazyva and standard therapy in adults having an active kidney disease known as lupus… Read more

Inluriyo: FDA Approves New Once-Daily Pill for ESR1-Mutated Advanced Breast Cancer in Patients Previously on Hormone Therapy

Inluriyo (imlunestrant) is a new oral treatment for certain types of locally advanced or metastatic breast cancer that has progressed after at least one round of hormone therapy. The FDA has approved it for people whose… Read more

Uzedy: FDA Approves Once-a-Month Subcutaneous Injectable Risperidone for Bipolar I Disorder

Uzedy is a long-acting injectable form of risperidone, a medicine used to treat serious mental health conditions like schizophrenia and bipolar I disorder (BD-I). It’s the first version of risperidone that’s given as a shot… Read more

Rybelsus: FDA Approves the Only Oral GLP-1 Medicine to Reduce Cardiovascular Risk in Adults with Type 2 Diabetes

Rybelsus (semaglutide) is a once-daily pill used to help lower blood sugar in adults with type 2 diabetes (T2D). It belongs to a group of medicines called GLP-1 receptor agonists. The FDA has now approved… Read more

Kygevvi: FDA Approves First Oral Treatment for Thymidine Kinase 2 Deficiency (TK2d)

Kygevvi is a new oral medicine for people with thymidine kinase 2 deficiency (TK2d), an extremely rare genetic condition affecting the muscles. The FDA has approved it for the treatment of adults and children with… Read more

Darzalex Faspro: A New Treatment for High-Risk Smoldering Multiple Myeloma

Darzalex Faspro is a medicine used to treat adults with multiple myeloma, a type of blood cancer, and amyloidosis, a rare condition where abnormal proteins build up in organs. It’s also the first treatment approved… Read more

Caplyta: A New Add-On Option for Adults With Depression

Caplyta (lumateperone) is a once-daily oral medicine now approved to be used with antidepressants to treat major depressive disorder (MDD) in adults. It belongs to a group of medicines called atypical antipsychotics. While experts don’t… Read more

FDA Approves Combined Use of Zepzelca and Atezolizumab as First-Line Maintenance Treatment for Advanced Small-Cell Lung Cancer

Zepzelca (lurbinectedin) is a chemotherapy medicine that damages the DNA of cancer cells by disrupting their protein function and ability to repair DNA. This action makes it difficult for cancer cells to grow, survive, and… Read more