The FDA has amended its Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of bivalent formulations of the products as a single booster dose in persons ≥12 years old (Pfizer) or ≥18 years old (Moderna) whose most recent COVID-19 vaccine dose was a monovalent product given ≥2 months previously as a booster or for completion of a primary series. The bivalent formulations are not authorized for primary immunization. Monovalent Pfizer and Moderna COVID-19 vaccines are no longer...

The FDA has approved Otovel (Arbor), a combination of the fluoroquinolone antibiotic ciprofloxacin 0.3% and the corticosteroid fluocinolone acetonide 0.025%, for otic treatment of acute otitis media with tympanostomy tubes (AOMT) in children ≥6 months old. It is the second fluoroquinolone/corticosteroid combination to be approved for this indication; ciprofloxacin 0.3%/dexamethasone 0.1% (Ciprodex) has been available for many years. In December 2015, a suspension of ciprofloxacin 6% (Otiprio) was approved for otic treatment of bilateral otitis media with effusion in children...

The FDA has approved tavaborole 5% solution (Kerydin – Anacor Pharmaceuticals) for topical treatment of toenail onychomycosis due to Trichophyton rubrum or Trichophyton mentagrophytes. It is the first oxaborole antifungal drug to be approved for this indication.

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).

In 2012, the FDA required manufacturers of HMG-CoA reductase inhibitors (statins) to add a warning to their labels about reports of increased blood glucose and glycosylated hemoglobin (HbA1c) levels. Since then, several new studies have been published.

Omalizumab (Xolair – Genentech), a recombinant anti-IgE monoclonal antibody FDA-approved for treatment of allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic urticaria, has now also been approved for use in conjunction with food allergen avoidance to reduce IgE-mediated food allergic reactions caused by accidental exposure in patients ≥1 year old. Omalizumab is the first drug to be approved in the US to reduce allergic reactions to more than one food. Palforzia, an oral peanut allergen powder, was approved in 2020 to mitigate allergic reactions caused by...

Belbuca (Endo), a buccal formulation of the partial opioid agonist buprenorphine, has been approved by the FDA for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. Buprenorphine is also available as a transdermal patch (Butrans) and in a parenteral formulation (Buprenex, and generics) for treatment of pain. A sublingual formulation of buprenorphine and buccal and sublingual formulations containing buprenorphine and the opioid antagonist naloxone are approved for use as alternatives to methadone for treatment of opioid...

Tapinarof 1% cream (Vtama – Dermavant), an aryl hydrocarbon receptor (AhR) agonist, has been approved by the FDA for topical treatment of atopic dermatitis in patients ≥2 years old. Tapinarof is the first AhR agonist to be approved in the US for this indication. It was approved in 2022 for treatment of plaque psoriasis in adults.

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 oral cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali – Novartis) has been approved by the FDA for use in combination with an aromatase inhibitor for first-line endocrine-based therapy in postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Ribociclib is also available copackaged with the aromatase inhibitor letrozole (Femara, and generics) as Kisqali Femara Co-Pack. Ribociclib is the second CDK 4/6 inhibitor to be approved in the US for this indication;...