AD-Detect (Quest), a blood test to evaluate Alzheimer's disease risk, is being marketed directly to consumers. It has not been cleared or approved by the FDA (laboratory-developed tests like this one currently do not need FDA authorization to be marketed).

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...

Since 2007, antimicrobial prophylaxis for dental procedures has been recommended to prevent viridans group streptococcal infective endocarditis only for patients at highest risk of an adverse outcome. Limiting use to such patients does not appear to have led to an increased incidence of infective endocarditis or increased mortality due to infective endocarditis.

Trofinetide (Daybue – Acadia), a synthetic analog of glycine-proline-glutamate, has been approved by the FDA for treatment of Rett syndrome in patients ≥2 years old. It is the first drug to be approved in the US for treatment of Rett syndrome.

The FDA has approved Crexont (Amneal), an extended-release capsule formulation of carbidopa/levodopa, for treatment of Parkinson's disease (PD), postencephalitic parkinsonism, and parkinsonism associated with carbon monoxide or manganese intoxication. Crexont contains a combination of immediate-release carbidopa/levodopa granules and extended-release levodopa pellets. An extended-release carbidopa/levodopa oral capsule (Rytary) has been available from the same manufacturer for years; the patent for Rytary expires in 2025.

Emrosi (Journey), an oral, low-dose, biphasic-release formulation of the tetracycline antibiotic minocycline, has been approved by the FDA for once-daily treatment of inflammatory lesions of rosacea (papules and pustules) in adults. Low-dose, biphasic-release doxycycline (Oracea, and generics) has been available for years for treatment of papulopustular rosacea.

The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupilumab is the first biologic drug to be approved in the US for this indication. It has been available for years for treatment of asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis.

The FDA has approved the intravenously administered beta₁-adrenergic blocker landiolol (Rapiblyk – AOP) for short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter. Esmolol (Brevibloc, and generics), another IV beta blocker, was approved earlier for the same indication.

Mepolizumab (Nucala – GSK), a subcutaneously injected interleukin-5 (IL-5) antagonist, has been approved by the FDA for add-on maintenance treatment of adults who have inadequately controlled chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. Mepolizumab is also approved for treatment of asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome.

The FDA has approved the nonsteroidal mineralocorticoid receptor antagonist (MRA) finerenone (Kerendia) to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), and urgent HF visits in adults with HF with a left ventricular ejection fraction (LVEF) ≥40%. Finerenone was approved in 2021 to reduce the risk of kidney disease progression and cardiovascular events in adults with chronic kidney disease (CKD) associated with type 2 diabetes.