The FDA has approved Entadfi (Veru), a fixed-dose combination of the 5α-reductase inhibitor finasteride and the phosphodiesterase type 5 (PDE5) inhibitor tadalafil, for initial treatment of benign prostatic hyperplasia (BPH) in men with an enlarged prostate; use of the drug is limited to 26 weeks. Entadfi is the first 5α-reductase inhibitor/PDE5 inhibitor combination to become available in the US. Finasteride (Proscar, and generics) and tadalafil (Cialis, and generics) are also available separately.

The FDA has approved the intravenously administered synthetic vasopressin analog terlipressin (Terlivaz – Mallinckrodt) to improve kidney function in adults with hepatorenal syndrome (HRS) and a rapid decline in kidney function. Terlipressin is the first drug to be approved for this indication in the US; it has been available in Europe and elsewhere for year

The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax) to allow for their use as a second booster dose ≥4 months after a first booster dose in adults ≥50 years old and in persons aged ≥12 years (Pfizer) or ≥18 years (Moderna) who have undergone solid organ transplantation or have a condition that compromises the immune system to a similar extent.

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 goal of asthma treatment is to control symptoms, prevent exacerbations, and maintain normal lung function. Management of acute exacerbations in the emergency department is not discussed here.

In a randomized, placebo-controlled trial, the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance – Boehringer Ingelheim/Lilly) reduced the composite risk of cardiovascular death or hospitalization for worsening heart failure (HF) in patients with heart failure with reduced ejection fraction (HFrEF), whether or not they had type 2 diabetes. To date, empagliflozin has not been approved by the FDA for such use. The SGLT2 inhibitor dapagliflozin (Farxiga) was approved by the FDA for this indication earlier this year.

Teprotumumab-trbw (Tepezza - Horizon), an insulin-like growth factor-1 receptor (IGF-1R) inhibitor, has been approved by the FDA for IV treatment of thyroid eye disease. It is the first drug to be approved in the US for this indication.

Amivantamab-vmjw (Rybrevant – Janssen), an EGFR-MET bispecific antibody, has received accelerated approval from the FDA for IV treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations in adults whose disease has progressed on or after platinum-based chemotherapy. It is the first bispecific antibody to become available in the US for this indication. Accelerated approval of the drug was based on the overall response rate and duration of response.

Delandistrogene moxeparvovec-rokl (Elevidys – Sarepta), an adeno-associated virus (AAV) vector-based gene therapy, has received accelerated approval from the FDA for treatment of ambulatory children 4-5 years old with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the dystrophin gene. It is the first gene therapy to be approved in the US for treatment of DMD. Accelerated approval was based on expression of microdystrophin in skeletal muscle, a surrogate endpoint.

Yutiq (Eyepoint), an intravitreal implant containing the corticosteroid fluocinolone acetonide, has been approved by the FDA for treatment of chronic noninfectious uveitis affecting the posterior segment of the eye. It is the third fluocinolone acetonide intravitreal implant to be approved in the US; Retisert, which is approved for the same indication as Yutiq, and Iluvien, which is approved for treatment of diabetic macular edema, were approved earlier. A dexamethasone intravitreal implant (Ozurdex) is approved by the FDA for treatment of noninfectious uveitis and macular...