The FDA has approved the oral GABA_A receptor modulator zuranolone (Zurzuvae – Sage Therapeutics/Biogen) for treatment of postpartum depression (PPD). Zuranolone is the second drug to be approved for this indication; brexanolone (Zulresso), another GABA_A receptor modulator, was approved for IV treatment of PPD in 2019.

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio – Lilly) has been approved by the FDA for use in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.1It was previously approved for the same indication, but patients were also required to have a Ki-67 score ≥20%. About 70% of all breast cancers are HR-positive and HER2-negative. Ki-67 is a...

The tissue plasminogen activator (tPA) tenecteplase (TNKase – Genentech) has been approved by the FDA for treatment of acute ischemic stroke in adults. It is the second tPA to be approved in the US for this indication; alteplase (Activase) was approved in 1996. Tenecteplase was approved in 2000 to reduce the risk of death associated with acute ST-elevation myocardial infarction (STEMI).

Prademagene zamikeracel (Zevaskyn – Abeona Therapeutics), an autologous cell sheet-based gene therapy, has been approved by the FDA for treatment of wounds in patients with recessive dystrophic epidermolysis bullosa. It is the first autologous cell sheet-based gene therapy to be approved in the US for this indication. Beremagene geperpavek gel (Vyjuvek), a herpes simplex virus type 1 vector-based gene therapy, is approved for once-weekly use in patients ≥6 months old with recessive dystrophic epidermolysis bullosa.

Uzedy, an extended-release, subcutaneous (SC) formulation of the second-generation antipsychotic drug risperidone, was approved by the FDA in 2023 for treatment of schizophrenia in adults. It has now been approved for use as monotherapy or in combination with lithium or valproate for maintenance treatment of bipolar I disorder in adults. Extended-release, intramuscular (IM) formulations of risperidone (Risperdal Consta and Rykindo) are also approved for treatment of bipolar I disorder (see Table 1).

The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga – AstraZeneca) was approved by the FDA in 2020 to reduce the risk of cardiovascular death and hospitalization for heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF). The indication has now been expanded to include a reduction in the risk of urgent HF visits and use in adults with any left ventricular ejection fraction (LVEF).

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.

Attention-deficit/hyperactivity disorder (ADHD) is a common chronic neurodevelopmental disorder often diagnosed in school-age children that frequently persists into adulthood.Pharmacologic treatment of ADHD has been associated with reduced risks of substance abuse, criminal behavior, unintentional injuries, serious traffic accidents, and all-cause mortality. Drugs approved by the FDA for treatment of ADHD are listed in Table 1.

View the Comparison Table: Inhaled Drugs for Treatment of COPD

The oral sphingosine 1-phosphate (S1P) receptor modulator etrasimod (Velsipity – Pfizer) has been approved by the FDA for treatment of moderately to severely active ulcerative colitis in adults. It is the second oral S1P receptor modulator to be approved in the US for this indication; ozanimod (Zeposia) was the first.