The FDA has approved isavuconazonium sulfate (Cresemba – Astellas) for intravenous and oral treatment of invasive aspergillosis and invasive mucormycosis in adults. Isavuconazonium sulfate is a prodrug of isavuconazole, a broad-spectrum triazole antifungal.

The FDA has approved two new inhalers for long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). Seebri Neohaler (Novartis) contains the long-acting anticholinergic glycopyrrolate. Utibron Neohaler (Novartis) contains both glycopyrrolate and the long-acting beta2-adrenergic agonist (LABA) indacaterol. Glycopyrrolate/indacaterol is the third fixed-dose combination of a long-acting anticholinergic and a LABA to become available in the US; umeclidinium/vilanterol (Anoro Ellipta) and tiotropium/olodaterol (Stiolto Respimat) were approved...

The FDA has approved voretigene neparvovec-rzyl intraocular suspension (Luxturna – Spark), an adeno-associated virus vector-based gene therapy, for treatment of confirmed biallelic RPE65 mutation-associated retinal dystrophy in patients who have viable retinal cells. It is the first gene replacement therapy approved in the US that targets a disease caused by mutations in a specific gene and the first pharmacologic treatment to be approved for this disorder.

The FDA has approved rifamycin (Aemcolo – Cosmo/ Aries), a minimally absorbed oral antibiotic, for treatment of adults with travelers' diarrhea (TD) caused by noninvasive strains of Escherichia coli. It is not recommended for treatment of diarrhea that is complicated by fever and/or bloody stools. Topical and injectable formulations of rifamycin have been used in Europe for other indications for many years.

The FDA has approved a sublingual tablet (Nocdurna – Ferring) and a nasal spray (Noctiva – Avadel) formulation of desmopressin acetate for treatment of nocturia due to nocturnal polyuria in adults who wake up ≥2 times per night to void. Nocdurna and Noctiva are the first two products to be approved in the US for this indication. Higher-strength nasal spray and oral tablet formulations of desmopressin (DDAVP, and others) have been available for years for treatment of diabetes insipidus and primary nocturnal enuresis (bedwetting in children). In 2007, the indication for primary...

The FDA has approved letermovir (Prevymis – Merck), a cytomegalovirus (CMV) DNA terminase complex inhibitor, for prophylaxis of CMV infection and disease in CMV-seropositive adult recipients of an allogeneic hematopoietic cell transplant (HCT). Letermovir is the first CMV DNA terminase complex inhibitor to be approved in the US and the only drug specifically indicated for CMV prophylaxis in HCT patients. It is not approved for treatment of CMV infection.

Brolucizumab-dbll (Beovu — Novartis), a vascular endothelial growth factor (VEGF) inhibitor, has been approved by the FDA as an intravitreal injection for treatment of neovascular (wet) age-related macular degeneration (AMD). It is the fourth VEGF inhibitor to be approved in the US for this indication; bevacizumab (Avastin, and others), a VEGF inhibitor FDA-approved for treatment of breast cancer and other malignancies, has been used off-label for this indication for years.

A 0.24% ophthalmic solution of the second-generation H₁-antihistamine cetirizine (Zerviate – Eyevance) is now available by prescription for treatment of ocular itching associated with allergic conjunctivitis in patients ≥2 years old. Oral cetirizine (Zyrtec, and others), which is used for treatment of allergic conjunctivitis and rhinitis, has been available over the counter (OTC) for years.

The FDA has approved a subcutaneous formulation of the recombinant human anti-CD20 antibody ofatumumab (Kesimpta – Novartis) for treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). Kesimpta is the second anti-CD20 antibody to be approved for these indications; IV ocrelizumab (Ocrevus), which is also approved for treatment of primary progressive MS, was the first. An IV formulation of ofatumumab (Arzerra) has...

The FDA has approved mannitol powder for oral inhalation (Bronchitol – Chiesi) as add-on maintenance treatment to improve pulmonary function in adults with cystic fibrosis (CF). This product has been available in Europe for the same indication since 2012. Another formulation of mannitol inhalation powder (Aridol) is approved in the US for assessment of bronchial hyperresponsiveness.