FDA OKs New Steroid-Free Skin Cream for Hand Eczema

July 24, 2025 – The FDA has approved a new treatment as the first and only skin cream for a specific type of hand eczema that affects about 1 in every 10 people globally. The cream,… Read more

FDA Approves First Oral Treatment for Rare Swelling Disorder

July 8, 2025 – The FDA has approved the first-ever pill to stop attacks of a rare genetic swelling disorder while they’re happening. The drug, known as sebetralstat but sold as Ekterly, is for adults… Read more

Vybrique Gets FDA Nod as a First Oral Film for Treating Erectile Dysfunction

Vybrique (sildenafil) is a new form of treatment for erectile dysfunction (ED) in adult men. It’s the first version of sildenafil available in the U.S. as a single-dose oral film that dissolves on your tongue… Read more

Calquence Plus Venclexta: FDA Approves First All‑Oral Fixed‑Duration Regimen for Adults With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

The FDA has approved a new combination treatment for adults with certain cancers of the blood and lymphatic system. The targeted regimen combines Calquence (acalabrutinib) tablets with Venclexta (venetoclax) for adults with previously untreated chronic lymphocytic… Read more

FDA Expands Palynziq to Adolescents

Palynziq (pegvaliase-pqpz) is a prescription enzyme treatment for phenylketonuria (PKU), a genetic condition that causes a buildup of phenylalanine (Phe) in your blood. This medicine provides an enzyme that stands in for the one your… Read more

Bysanti: FDA Approves New Atypical Antipsychotic Pill for Adults with Schizophrenia or Manic/Mixed Episodes in Bipolar I Disorder

Bysanti (milsaperidone) is a new FDA-approved oral medicine for treating certain mental health conditions in adults. It belongs to a group of medicines called atypical antipsychotics and is approved for the treatment of schizophrenia, as… Read more

Keytruda With Paclitaxel: FDA Approves New Combination Therapy for Certain Cancers Affecting the Ovaries, Fallopian Tubes, or Peritoneum

The FDA has approved a new combination therapy for adults with epithelial cancers that start in the ovaries, fallopian tubes, or lining of the abdomen (peritoneum). This treatment is meant for patients whose cancers express… Read more

Hernexeos: FDA Approves First-Line Use for Certain Advanced Non-Small-Cell Lung Cancers With HER2 Mutations

Hernexeos (zongertinib) is a prescription medicine known as a kinase inhibitor that is used for treating adults with advanced non-small-cell lung cancer (NSCLC) that cannot be removed surgically or has spread to other parts of… Read more

Zycubo: FDA Approves First Under-the-Skin Shot for Treating Menkes Disease in Children

Zycubo (copper histidinate) is a new under-the-skin injection that the FDA has approved for treating children with a rare genetic condition that affects copper metabolism, known as Menkes disease. Menkes disease is caused by mutations… Read more

Lunsumio Velo: FDA Approves a Convenient Under-the-Skin Shot for Relapsed or Refractory Follicular Lymphoma

Lunsumio Velo  (mosunetuzumab-axgb) is a new under-the-skin (subcutaneous) injection version of the anticancer medicine Lunsumio intravenous infusion. The FDA has granted accelerated approval to Lunsumio Velo for treating adults with follicular lymphoma that has come back (relapsed)… Read more