The FDA has approved the interleukin-2 (IL-2) receptor-directed fusion protein denileukin diftitox (Lymphir – Citius) for treatment of relapsed or refractory stage I-III cutaneous T-cell lymphoma in adults who received at least one prior systemic therapy. Lymphir is a reformulated, purified version of Ontak, which was voluntarily withdrawn from the market in 2014 because of manufacturing issues.

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.

Now that glucosamine and chondroitin, 2 favorite over-the-counter remedies for painful osteoarthritis (OA) of the knee, have been at least somewhat discredited, some patients will be asking about alternatives. One of these is periodic intra-articular injection of a corticosteroid or hyaluronic acid preparation.

The FDA has approved Viekira Pak (Abbvie), a fixed-dose combination of two new direct-acting antiviral agents (ombitasvir, paritaprevir) with the pharmacologic enhancer ritonavir in one tablet, co-packaged with a third new direct-acting antiviral agent (dasabuvir) in a second tablet, for oral treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Genotype 1 is responsible for 70-80% of HCV infections in the US.

The FDA has approved Entresto (Novartis), an oral fixed-dose combination of the neprilysin inhibitor sacubitril and the angiotensin receptor blocker (ARB) valsartan, to reduce the risk of cardiovascular death and heart failure hospitalization in patients with heart failure with reduced ejection fraction. Sacubitril is the first neprilysin inhibitor to become available in the US.

Three oral poly(ADP-ribose) polymerase (PARP) inhibitors have been approved by the FDA for treatment of advanced, recurrent ovarian cancer. Olaparib (Lynparza – AstraZeneca), niraparib (Zejula – Tesaro), and rucaparib (Rubraca – Clovis) are each approved for somewhat different indications and for patients with different biomarkers (see Table 2).

The FDA has approved a subcutaneous (SC) extended-release formulation of the mu-opioid receptor partial agonist and kappa-opioid receptor antagonist buprenorphine (Sublocade – Indivior) for once-monthly treatment of moderate to severe opioid use disorder. Sublocade is the first injectable buprenorphine product to be approved in the US. Buprenorphine is also available in sublingual formulations with or without the opioid antagonist naloxone, in a buccal formulation with naloxone, and as a subdermal implant (Probuphine).

The FDA has approved erenumab-aooe (Aimovig – Amgen/Novartis), a once-monthly, subcutaneously-injected, monoclonal antibody against the calcitonin gene-related peptide receptor, for preventive treatment of migraine in adults. It is the first drug in its class to be approved by the FDA.