The FDA has approved Aurlumyn (Eicos Sciences), an IV formulation of the prostacyclin analog iloprost, to reduce the risk of digit amputation in adults with severe frostbite. Iloprost is the first drug to be approved by the FDA for treatment of severe frostbite; it has been used off-label for this indication in the EU and elsewhere for decades. In the US, iloprost is also available as an inhaled formulation (Ventavis) for treatment of pulmonary arterial hypertension.

Clostridioides (formerly Clostridium) difficile infection (CDI) is the most common infectious cause of healthcare-associated diarrhea in adults. Guidelines on management of CDI have recently been updated.

Colchicine (Colcrys, and others), which has been available in the US for decades for prophylaxis and treatment of gout flares and other indications in oral formulations that contain 0.6 mg of the drug, has now been approved in 0.5-mg tablets as Lodoco (Agepha) to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adults with established atherosclerotic disease or multiple risk factors for cardiovascular disease.

The oral kinase inhibitor capivasertib (Truqap – AstraZeneca), a first-in-class AKT inhibitor, has been approved by the FDA for use in combination with the selective estrogen receptor degrader (SERD) fulvestrant (Faslodex, and generics) for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adults with one or more PIK3CA/AKT1/PTEN-alterations who had disease progression on at least one endocrine-based regimen for metastatic disease or recurrence on or within 12 months of completing...

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.

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.

Tofersen (Qalsody – Biogen), an intrathecally administered antisense oligonucleotide, has received accelerated approval from the FDA for treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene. About 2% of patients with ALS have mutations in the SOD1 gene. Tofersen is the first drug to be approved in the US that targets a genetic cause of ALS. Accelerated approval of the drug was based on the surrogate endpoint of a reduction in plasma neurofilament light chain, which is considered likely to predict clinical...

Tirbanibulin, a microtubule inhibitor, has been approved by the FDA as a 1% ointment (Klisyri – Almirall) for topical treatment of actinic keratosis of the face or scalp.

The FDA has approved the interleukin (IL)-6 inhibitor sarilumab (Kevzara – Sanofi/Regeneron) for treatment of polymyalgia rheumatica (PMR) in adults who had an inadequate response to corticosteroids or cannot tolerate a corticosteroid taper. Sarilumab is the first biologic drug to be approved for treatment of PMR; it was previously approved for treatment of rheumatoid arthritis.

Onychomycosis is caused most commonly by Trichophyton rubrum or T. mentagrophytes. About 10% of all persons worldwide and 40% of those ≥60 years old are believed to have the disease. Risk factors include older age, diabetes, poor peripheral circulation, smoking, HIV infection, psoriasis, and immunosuppression. Left untreated, onychomycosis can cause nail plate destruction, ingrown nails, and (particularly in patients with diabetes) secondary infections. Guidelines on treatment of onychomycosis have been published.