FDA Approves Jideytro for Advanced ROS1-Positive Lung Cancer

The FDA has approved Jideytro (zidesamtinib), a medicine for adults with a type of lung cancer called non-small-cell lung cancer (NSCLC). This approval is for cancer that has spread within the chest or to other… Read more

FDA Approves Kerendia for Adults With Type 1 Diabetes and Kidney Disease

What Is Kerendia and How Does It Work? The FDA has approved Kerendia (finerenone) for adults who have chronic kidney disease (CKD) linked to type 1 diabetes. CKD is a condition where the kidneys slowly… Read more

FDA Approves Etcamah Combination for Advanced Breast Cancer

What Is Etcamah, and How Does It Work? The FDA has approved Etcamah (camizestrant) to treat adults with advanced breast cancer. It is used for tumors that are hormone receptor (HR)-positive and human epidermal growth… Read more

FDA Approves Hyrnuo as First Treatment Choice for Specific Type of Lung Cancer

What Is Hyrnuo and How Does It Work? The FDA has granted accelerated approval to Hyrnuo (sevabertinib) for adults with a specific type of advanced lung cancer. It is used for non-squamous non-small-cell lung cancer… Read more

Tremfya: First Fully Under-the-Skin IL-23 Inhibitor Shot Approved for Ulcerative Colitis and Crohn’s Disease

Tremfya (guselkumab) is a lab-made, dual-acting antibody medication that reduces inflammation by targeting the interleukin-23 (IL-23) protein and blocking a majority of the cells that produce it.It is available by prescription.The FDA has now approved… Read more

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 body… 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… 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 nephritis… 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 under… Read more