(continued)
- Otarmeni: FDA Approves One-Time Gene Therapy for OTOF-Associated Genetic Hearing Loss
- Tzield: FDA Expands Immune Therapy Use to Delay Stage III Type 1 Diabetes in Kids as Young as 1 Year Old
- Dupixent: FDA Approves First Under-the-Skin Biologic Shot for Children Ages 2-11 Years With Chronic Hives Not Controlled With Antihistamines
- Idvynso: FDA Approves New Once-Daily Combo Pill for Adults With HIV-1 Infection
- Filspari: FDA Approves Dual-Acting Oral Therapy for Focal Segmental Glomerulosclerosis
- Eylea HD: FDA Allows Up to 5-Month Dosing With Higher-Strength Formulation for Vision-Threatening Eye Conditions
- Awiqli: FDA Approves First and Only Once-Weekly Long-Acting Basal Insulin for Adults With Type 2 Diabetes
- Kresladi: FDA Approves First One-Time Gene Therapy for Children With Severe Leukocyte Adhesion Deficiency Type I
- Lynavoy: FDA Approves First Treatment for Severe Itching in Adults With Primary Biliary Cholangitis
- Opdivo: FDA Approves Immunotherapy With Chemo for Previously Untreated Hodgkin Lymphoma
- Imcivree: FDA Approves Once-Daily Under-the-Skin Injection for Weight Loss in Patients With Acquired Hypothalamic Obesity
- Arexvy: FDA Expands Vaccine Use to Help Prevent RSV Lung Disease in At‑Risk Adults
- Cosentyx: FDA Approves Biologic Under-the-Skin Shot for Teens With Moderate-to-Severe Hidradenitis Suppurativa
- Sotyktu: FDA Approves First Selective, Once-Daily Oral TYK2 Inhibitor for Adults With Active Psoriatic Arthritis
- Tecvayli Plus Darzalex Faspro: FDA Approves Under‑the‑Skin Combo Immune Therapy as a New Second-Line Option for Multiple Myeloma
- Hernexeos: FDA Approves First-Line Use for Certain Advanced Non-Small-Cell Lung Cancers With HER2 Mutations
- Desmoda: FDA Approves the First and Only Liquid Version of Desmopressin to Ensure Precise Dosing in Patients With Central Diabetes Insipidus
- Dupixent: FDA Approves First and Only Medicine for Allergic Fungal Rhinosinusitis in Adults and Children Ages 6 Years and Older
- Loargys: FDA Approves the First and Only Injectable Enzyme Therapy, Paired With a Low‑Protein Diet, to Lower High Arginine Levels in Patients Ages 2 Years or Older With Arginase 1 Deficiency
- Calquence Plus Venclexta: FDA Approves First All‑Oral Fixed‑Duration Regimen for Adults With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- Bysanti: FDA Approves New Atypical Antipsychotic Pill for Adults with Schizophrenia or Manic/Mixed Episodes in Bipolar I Disorder
- Rybrevant Faspro: FDA Approves Once-Monthly Dosing in Combination With Lazcluze for EGFR-Mutated Lung Cancer
- Adquey: FDA Approves New Nonsteroidal Ointment for Mild to Moderate Eczema
- Wakix: FDA Expands Approval to Treat Sudden Muscle Weakness in Children With Narcolepsy
- FDA Approves Rybrevant Faspro: A Time-Saving Under-the-Skin Injection for Use in Combination With Lazcluze for EGFR-Mutated Lung Cancer
- Keytruda With Paclitaxel: FDA Approves New Combination Therapy for Certain Cancers Affecting the Ovaries, Fallopian Tubes, or Peritoneum
- Vybrique Gets FDA Nod as a First Oral Film for Treating Erectile Dysfunction
- FDA Approves Darzalex Faspro as Part of a New First-Line Quadruplet Regimen for Multiple Myeloma
- Zycubo: FDA Approves First Under-the-Skin Shot for Treating Menkes Disease in Children
- FDA Approves Cablivi: New Treatment Option for Rare Blood Clotting Disorder in Children Ages 12 Years and Older