New Drugs

Vaccine for immunization during pregnancy to prevent RSV disease in infants; also used to prevent RSV disease in individuals ≥ 60 years of age.

Vaccinia virus vaccine for active immunization against smallpox in high-risk persons.

A new anti-tissue factor pathway inhibitor antibody for hemophilia B.

SC transthyretin-directed small interfering RNA for polyneuropathy in hereditary transthyretin-mediated amyloidosis.

IV enzyme that depletes plasma asparagine for treatment of acute lymphoblastic leukemia.

Gene therapy for treatment of moderately severe to severe hemophilia B in adults.

A new long-acting antibody for the prevention of respiratory syncytial virus (RSV) in neonates, infants, and children up to 24 months of age.

Oral ileal bile acid transporter inhibitor for treating pruritus in progressive familial intrahepatic cholestasis.

A new B-cell maturation antigen (BCMA)-directed T-cell IV immunotherapy for adults with multiple myeloma.

A new CD20/CD-3 binding monoclonal antibody for B-cell lymphoma.

Vaccine for active immunization against COVID-19 in individuals 6 months of age or older.

Oral thrombopoietin receptor agonist for thrombocytopenia in chronic liver disease or chronic immune thrombocytopenia.

SC BCMA-directed monoclonal antibody for relapsed/refractory multiple myeloma.

Cannabinoid oral solution for adjunctive therapy in specific types of seizures.

SC CD20-directed CD3 T-cell engager mAb for lymphoma.

Angiopoietin-like 3 (ANGPTL3) protein inhibitor mAb for homozygous familial hypercholesterolemia.

IV gene therapy for routine prophylaxis to prevent/reduce bleeding episodes in hemophilia B.

A new MC4 receptor agonist for weight management in patients with Bardet-Biedl syndrome or other specified genetic conditions.

SC selective immunomodulating agent; biosimilar to Stelara.

A new IV direct P2Y12 platelet receptor inhibitor for patients with coronary artery disease undergoing percutaneous coronary intervention (PCI).

Oral JAK3/TEC kinase inhibitor for severe alopecia areata.

Oral ileal bile acid transporter inhibitor for cholestatic pruritus in Alagille syndrome.

Oral CGRP antagonist for acute migraine in adults.

Recombinant protein, adjuvanted vaccine to prevent COVID-19.

IV/SC interleukin-23 p19 antagonist for moderate to severe ulcerative colitis.

A new topical microtubule inhibitor for actinic keratosis on the face or scalp.

PD-1 inhibitor/LAG-3 checkpoint inhibitor mAb combination for unresectable or metastatic melanoma.

GnRH receptor antagonist for advanced prostate cancer.

Prophylaxis of influenza in an officially declared pandemic situation.

Alpha1-antitrypsin replenisher for long-term use in patients with alpha1-antitrypsin deficiency and emphysema.

A new oral dual orexin receptor antagonist for insomnia in adults.

Biosimilar to Lucentis.

IV beta-blocker for short-term reduction of ventricular rate in patients with supraventricular tachycardia.

SC human growth hormone analogue for growth failure in children or growth hormone deficiency in adults.

A new interleukin-36 inhibitor for generalized pustular psoriasis.

Vaccine for active immunization against COVID-19 in individuals 6 months of age or older.

Oral antiviral for treatment of human smallpox disease.

New granule formulation for use in children 2 years of age or older.

CD19-directed cytolytic mAb for neuromyelitis optica spectrum disorder.

A new oral, live-attenuated vaccine against diarrheal disease caused by Vibrio cholerae for patients traveling to cholera-affected countries.

A biosimilar to Avastin.

A new oral soluble guanylate cyclase (sGC) stimulator for symptomatic heart failure with reduced ejection fraction (HFrEF) in adults.

A new prodrug of levodopa/carbidopa for motor fluctuation in patients with advanced Parkinson’s disease.

Antiepileptic for adjunctive therapy in partial-onset seizures in adults.