Brella Sweat Control Patch (Candesant Biomedical), a sodium-containing transdermal patch, has been cleared by the FDA for in-office treatment of primary axillary hyperhidrosis in adults. It is the first patch to be approved in the US for this indication.

The FDA has required a new boxed warning in the label of the subcutaneously injected immunomodulatory drug glatiramer acetate (Copaxone, Glatopa, and generics) about a risk of anaphylaxis. Glatiramer has been used for years to treat relapsing forms of multiple sclerosis (MS).

The FDA has approved two new drugs for treatment of previously-treated unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer: fam-trastuzumab deruxtecannxki (Enhertu – Daiichi-Sankyo/AstraZeneca), an IV HER2-directed monoclonal antibody linked to the topoisomerase I inhibitor DXd, and tucatinib (Tukysa – Seagen), an oral tyrosine kinase inhibitor.

The FDA has approved mavacamten (Camzyos – MyoKardia/BMS), a modulator of cardiac myosin, to improve functional capacity and symptoms in adults with New York Heart Association (NYHA) class II or III obstructive hypertrophic cardiomyopathy (HCM) who have a baseline left ventricular ejection fraction (LVEF) ≥55%. Mavacamten is the first drug in its class to become available in the US.

The FDA has approved tirzepatide (Mounjaro – Lilly), a peptide hormone with activity at both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, to improve glycemic control in adults with type 2 diabetes. Tirzepatide, which is injected subcutaneously once weekly, is the first dual GIP/GLP-1 receptor agonist to become available in the US. Selective GIP receptor agonists are not available in the US; GLP-1 receptor agonists have been available for years.

The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for treatment of eosinophilic esophagitis (EoE) in patients ≥12 years old who weigh ≥40 kg and treatment of prurigo nodularis in adults. Dupilumab is the first drug to be approved in the US for each of these indications. It is also FDA-approved for treatment of atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis.

The FDA has approved sotatercept-csrk (Winrevair – Merck), a first-in-class activin signaling inhibitor, to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events in adults with WHO Group 1 pulmonary arterial hypertension (PAH).

The FDA has approved rezafungin (Rezzayo – Cidara/Melinta), an intravenous echinocandin antifungal, for once-weekly treatment of candidemia and invasive candidiasis (IC) in adults with limited or no alternative options. It is the first new drug to become available in the US in more than 15 years for treatment of systemic Candida infections.

The FDA has issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech mRNA-based vaccine for prevention of COVID-19 in persons ≥16 years old.

On December 18, 2020, the FDA issued an Emergency Use Authorization (EUA) for the Moderna mRNA-based vaccine for prevention of COVID-19 in persons ≥18 years old. The Pfizer-BioNTech mRNA-based vaccine received an FDA EUA for the same indication in persons ≥16 years old on December 11, 2020.