The FDA has approved Vybrique (IBSA), an oral film formulation of the phosphodiesterase type 5 (PDE5) inhibitor sildenafil, for treatment of erectile dysfunction (ED). Sildenafil oral tablets (Viagra, and generics) have been available since 1998. The manufacturer is promoting the new product as a "discreet, on-the-go" option that can be taken without water.

Plozasiran (Redemplo – Arrowhead), an apolipoprotein C-III (apoC-III)-directed small interfering ribonucleic acid (siRNA), has been approved by the FDA to reduce triglyceride levels in adults with familial chylomicronemia syndrome (FCS). It is the second drug to be approved in the US for this indication; the apoC-III-directed antisense oligonucleotide olezarsen (Tryngolza) was approved in 2024.

The FDA has approved Wegovy HD, a 7.2-mg dose of the injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide, for use in adults who have tolerated the 2.4-mg dose for at least 4 weeks and require additional weight reduction.

The FDA has approved Inqovi (Taiho Oncology), a fixed-dose combination of the nucleoside metabolic inhibitor decitabine and the cytidine deaminase inhibitor cedazuridine, for use in combination with venetoclax (Venclexta, and generics) for oral treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are ≥75 years old or who have comorbidities that prevent use of intensive induction chemotherapy. The combination was approved in 2020 for treatment of myelodysplastic syndromes (MDS). IV decitabine or azacitidine plus oral venetoclax has been used for treatment of newly...

The FDA has approved Winlevi (Sun), a 1% cream formulation of the androgen receptor inhibitor clascoterone, for treatment of acne vulgaris in patients ≥12 years old. It is the first topical androgen receptor inhibitor to be approved by the FDA.

The FDA has approved the injectable interleukin (IL)-17A/17F antagonist bimekizumab-bkzx (Bimzelx – UCB) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic treatment or phototherapy. Bimekizumab is the first IL-17A/17F antagonist to be approved in the US. It was approved in the European Union for the same indication in 2021.

The FDA has approved Symbravo (Axsome), an oral fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam and the 5-HT_1B/1D receptor agonist (triptan) rizatriptan (Maxalt, and generics), for acute treatment of migraine with or without aura in adults. It is the second combination of an NSAID and a triptan to be approved for migraine treatment. An oral fixed-dose combination of sumatriptan and naproxen (Treximet, and generics) is approved for use in patients ≥12 years old.

The FDA has approved orforglipron (Foundayo – Lilly), an oral small-molecule, nonpeptide glucagon-like peptide-1 (GLP-1) receptor agonist, to reduce excess body weight and maintain weight reduction long term in adults with obesity, or with overweight and at least one weight-related comorbidity. Orforglipron is the second oral GLP-1 receptor agonist to be approved in the US for this indication; an oral formulation of the peptide semaglutide (Wegovy) was approved in 2025.

Enlicitide (Lipfendra – Merck), an oral proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitor, has been approved by the FDA to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). It is the first oral PCSK9 inhibitor to be approved in the US; the other FDA-approved PCSK9 inhibitors (alirocumab [Praluent], evolocumab [Repatha], and lerodalcibep [Lerochol]) and the PCSK9-directed small interfering RNA inclisiran (Leqvio) are injected subcutaneously. Lipfendra was approved under...

In overactive bladder, involuntary bladder contractions due to detrusor overactivity result in urinary urgency, frequency, nocturia, and incontinence. The prevalence of the disorder increases with age. Nonpharmacologic treatment, including bladder training, urge suppression, pelvic floor muscle exercises, constipation management, modification of fluid intake, and avoidance of dietary irritants such as alcohol and caffeine, should be tried first.