The FDA has recently approved intradetrusor injection of onabotulinumtoxinA (Botox – Allergan) for treatment of overactive bladder in patients who cannot tolerate or have an inadequate response to anticholinergic therapy. Botox is also approved by the FDA for use in detrusor overactivity associated with a neurologic condition such as multiple sclerosis or spinal cord injury, and for chronic migraine, upper limb spasticity, axillary hyperhidrosis, cervical dystonia, blepharospasm, strabismus, and cosmetic reduction of wrinkles.

The FDA has approved testosterone undecanoate (Aveed – Endo), an injectable depot formulation, for use in men with hypogonadism who require testosterone replacement therapy.

The FDA has approved sugammadex (Bridion – Merck), a selective relaxant binding agent, for reversal of rocuronium- or vecuronium-induced neuromuscular blockade in adult surgical patients. It is the first selective relaxant binding agent to be approved in the US. Sugammadex has been available in the European Union, Japan, and elsewhere for several years. Previous FDA reviews of sugammadex did not result in approval because of concerns about a risk of anaphylaxis and other hypersensitivity reactions with its use.

The FDA has approved the immune checkpoint inhibitor pembrolizumab (Keytruda – Merck), a programmed death receptor-1 (PD-1) inhibitor, for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) that highly expresses programmed death-ligand 1 (PD-L1) and has no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) translocations. About 25% of patients with advanced NSCLC have tumors with high levels of PD-L1 expression (PD-L1 expressed on ≥50% of tumor cells). Pembrolizumab was approved earlier for treatment...

The FDA has approved the selective alpha_1A-adrenergic receptor agonist oxymetazoline as a 1% cream (Rhofade – Allergan) for topical treatment of persistent facial erythema of rosacea in adults. Brimonidine, a selective alpha₂-adrenergic receptor agonist, was approved in 2013 as a 0.33% gel (Mirvaso) for the same indication. Like Mirvaso, Rhofade is not indicated for treatment of inflammatory lesions of rosacea. Oxymetazoline has been available over the counter for many years as a nasal decongestant spray (Afrin, and others).

The FDA has approved the interleukin (IL)-23 blocker guselkumab (Tremfya – Janssen) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Guselkumab is the first selective IL-23 blocker to become available in the US.

The FDA has approved vericiguat (Verquvo – Merck), an oral soluble guanylate cyclase (sGC) stimulator, to reduce the risk of hospitalization for heart failure and cardiovascular (CV) death following a worsening heart failure event (hospitalization for heart failure or treatment with IV diuretics as an outpatient) in patients with symptomatic chronic heart failure and left ventricular ejection fraction (LVEF) <45%. Vericiguat is the second sGC stimulator to be marketed in the US. Riociguat (Adempas), which is FDA-approved for treatment of pulmonary arterial hypertension...

The investigational monoclonal antibody sotrovimab (VIR-7831; GSK/Vir Biotechnology) has been granted an FDA Emergency Use Authorization (EUA) for treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease, including hospitalization and death.1 Two other monoclonal antibody regimens are authorized for the same indication: casirivimab (REGN10933) and imdevimab (REGN10987) administered together, and bamlanivimab (LY-CoV555) and etesevimab (LYCoV016) administered together. The FDA revoked its EUA...

The CDC has issued new guidance allowing for an interval of up to 8 weeks between the first and second primary doses of an mRNA COVID-19 vaccine in certain patients 12-64 years old.1 Product labeling currently recommends a 3-week interval between the first two doses of the Pfizer/BioNTech mRNA vaccine (Comirnaty) and a 4-week interval between the first two doses of the Moderna mRNA vaccine (Spikevax). The new guidance is based on data suggesting that a longer interval can decrease the risk of myocarditis and may improve vaccine efficacy.

The oral Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly), which was previously approved by the FDA for treatment of moderately to severely active rheumatoid arthritis and treatment of COVID-19 in certain hospitalized adults, has now been approved for treatment of severe alopecia areata in adults. Baricitinib is the first systemic treatment to be approved in the US for this indication.