Vusolimogene oderparepvec (Tudriqev – Replimune), a genetically-modified herpes simplex virus type 1 (HSV-1) oncolytic therapy, has been granted accelerated approval by the FDA for use in combination with the programmed death receptor-1 (PD-1)-blocking antibody nivolumab (Opdivo) for treatment of unresectable advanced cutaneous melanoma in adults who had disease progression on a PD-1-blocking antibody-based regimen. About 30-50% of patients develop primary resistance to anti-PD-1 therapy. The oncolytic viral therapy talimogene laherparepvec (Imlygic) was approved in 2015 for...

Liraglutide (Victoza – Novo Nordisk), a glucagon-like peptide-1 (GLP-1) receptor agonist given by subcutaneous injection, has been approved by the FDA for treatment of patients with type 2 diabetes. It can be used alone or in addition to oral antidiabetic drugs such as metformin (Glucophage, and others) or glimepiride (Amaryl, and others). Liraglutide is not recommended for first-line therapy and is not approved for use with insulin.

The FDA has approved Mavyret (Abbvie) and Vosevi (Gilead), two new fixed-dose combinations of direct-acting antiviral (DAA) drugs, for treatment of chronic hepatitis C virus (HCV) infection caused by any of the six major HCV genotypes in patients without cirrhosis or with compensated cirrhosis. Both are approved for use in treatment-experienced patients. Mavyret is also approved for treatment-naive patients.

The FDA has approved Bijuva (TherapeuticsMD), a fixed-dose combination of estradiol and progesterone, for oral treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause in women with an intact uterus. The manufacturer is marketing Bijuva as "the first and only FDA-approved combination of bio-identical estradiol and bio-identical progesterone in a single daily oral capsule".

The FDA has approved pembrolizumab (Keytruda – Merck), a human programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma that has progressed following treatment with ipilimumab (Yervoy) and, if the patient is BRAF V600 mutation positive, a BRAF inhibitor. It is the fi rst PD-1 inhibitor to be marketed in the US. Nivolumab, another PD-1 inhibitor, is available in Japan. Pembrolizumab was previously known as lambrolizumab.

View the Comparison Chart: Some Vaccines for Adults

Bepotastine besilate 1.5% ophthalmic solution (Bepreve - ISTA Pharmaceuticals), an H₁-antihistamine, has been approved by the FDA for topical treatment of itching associated with allergic conjunctivitis in patients ≥2 years old. Bepotastine was first developed in an oral systemic formulation and has been used as such for treatment of allergic rhinitis in Japan.

The FDA has approved Xultophy 100/3.6 (Novo Nordisk), a fixed-ratio combination of insulin degludec and the GLP-1 (glucagon-like peptide-1) receptor agonist liraglutide, for once-daily treatment of adults with type 2 diabetes inadequately controlled on basal insulin (<50 units daily) or liraglutide (≤1.8 mg daily).

A new 2023-2024 formulation of the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax that was developed to more closely target currently circulating SARS-CoV-2 variants has been made available in the US under an FDA Emergency Use Authorization (EUA) for use in persons ≥12 years old. The original formulation of the Novavax vaccine is no longer authorized for use in the US. In September, updated formulations of the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) were licensed by the FDA for use in persons ≥12 years old and...

The FDA has approved lixisenatide (Sanofi), a short-acting injectable GLP-1 (glucagon-like peptide-1) receptor agonist, for once-daily treatment of adults with type 2 diabetes, both alone (Adlyxin) and in a fixed-ratio combination with insulin glargine (Soliqua 100/33). Lixisenatide has been available since 2013 in many other countries as Lyxumia. It is the fifth GLP-1 receptor agonist to be approved in the US.