A consolidated list of all the FDA approved medications during the month of April 2026.
- Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) New Indication
- For the treatment of agitation associated with dementia due to Alzheimer’s disease.
- Breztri (budesonide/glycopyrrolate/formoterol fumarate) New Indication
- For the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older.
- Caplyta (lumateperone) New Indication
- For the prevention of relapse in schizophrenia.
- Saphnelo Pen (anifrolumab) New Formulation
- For self-administration as a once-weekly autoinjector, for the treatment of adult patients with systemic lupus erythematosus (SLE) on top of standard therapy.
- Otarmeni (lunsotogene parvec-cwha)
- To treat acquired hypothalamic obesity (HO) in adults and pediatric patients aged 4 years and older.
- Dupixent (dupilumab) Expanded Indication
- Indication expanded to include children aged 2-11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite treatment with histamine 1 antihistamines (H1AH).
- Tzield (teplizumab-mzwv) Expanded Indication
- Indication expanded from eight years and older to as young as one year of age to delay the onset of stage 3 type 1 diabetes (T1D) in patients diagnosed with stage 2 T1D.
- Idvynso (doravirine/islatravir)
- For the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.
- Caldolor (ibuprofen) Expanded Indication
- In adults and pediatric patients aged 3 months and older for management of mild to moderate pain, including postoperative pain; management of moderate to severe pain, including postoperative pain.
- Rapiblyk (landiolol) Expanded Indication
- For use in pediatric patients (from birth to <18 years of age) with supraventricular tachycardia (SVT).
- Filspari (sparsentan) New Indication
- To reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome.
- Radiesse (calcium hydroxylapatite) New Indication
- For the treatment of wrinkles in the décolleté area in patients 22 years of age and older.
- Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Expanded Indication
- For the treatment of people with cystic fibrosis (CF) ages 2 and older who have a clinical diagnosis of CF and who have at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein.
- Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) Expanded Indication
- For the treatment of people with cystic fibrosis (CF) ages 6 and older with a variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein.
- Foundayo (orforglipron)
- In combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.
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