The FDA has approved adjunctive treatment with Dartisla ODT (Edenbridge), a new orally disintegrating tablet (ODT) formulation of the anticholinergic drug glycopyrrolate, to reduce symptoms of a peptic ulcer. Glycopyrrolate oral tablets (Robinul, Robinul Forte, and generics) were approved for the same indication in 1961.

Radicava ORS, an oral suspension formulation of the free radical scavenger edaravone (Mitsubishi Tanabe Pharma), has been approved by the FDA for treatment of amyotrophic lateral sclerosis (ALS). An IV formulation of edaravone (Radicava) has been available since 2017.

Lonapegsomatropin-tcgd (Skytrofa – Ascendis), a long-acting prodrug of recombinant human growth hormone (rhGH), has been approved by the FDA for once-weekly subcutaneous (SC) treatment of growth failure due to inadequate secretion of endogenous growth hormone in children ≥1 year old who weigh ≥11.5 kg. It is the first once-weekly rhGH product to be approved in the US; other available rhGH formulations are administered more frequently.

The FDA has approved Ryaltris (Hikma), a fixed-dose combination nasal spray containing the H1-antihistamine olopatadine hydrochloride (Patanase, and generics) and the corticosteroid mometasone furoate (Nasonex 24 HR Allergy, and generics), for treatment of seasonal allergic rhinitis symptoms in persons ≥12 years old. Ryaltris is the second intranasal antihistamine/corticosteroid combination to be approved for this indication; azelastine 0.1%/fluticasone propionate (Dymista, and generics), which is approved for use in persons ≥6 years old, was the first. Both products are available...

The FDA has approved a subcutaneously injected, extended-release formulation of the mu-opioid receptor partial agonist and kappa-opioid receptor antagonist buprenorphine (Brixadi – Braeburn) for once-weekly or once-monthly treatment of moderate to severe opioid use disorder. Brixadi is the second subcutaneously injected buprenorphine formulation to be approved in the US; Sublocade, which is administered once monthly, was the first. Buprenorphine is also available for treatment of opioid use disorder in sublingual formulations with and without the opioid antagonist...

The FDA has approved the hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) vadadustat (Vafseo – Akebia) for oral treatment of anemia due to chronic kidney disease (CKD) in adults who have been on dialysis for at least 3 months. Vadadustat is the second HIF-PHI to be approved in the US for this indication; daprodustat (Jesduvroq) was approved earlier, but it was withdrawn from the US market in 2024 for commercial reasons.

The FDA has approved depemokimab (Exdensur – GSK), a long-acting interleukin-5 (IL-5) antagonist, for add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in patients ≥12 years old. Depemokimab is the fourth IL-5-directed treatment to be approved in the US for this indication; the IL-5 antagonists mepolizumab (Nucala) and reslizumab (Cinqair) and the IL-5 receptor alpha antagonist benralizumab (Fasenra) were approved earlier.

Andexanet alfa (Andexxa – AstraZeneca), which received accelerated approval from the FDA in 2018 for urgent reversal of the anticoagulant effect of the direct factor Xa inhibitors apixaban (Eliquis) and rivaroxaban (Xarelto), has voluntarily been withdrawn from the market. Andexxa was the only drug FDA-approved for this indication in the US.

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 approved Vizz (Lenz Therapeutics), a 1.44% ophthalmic solution of the cholinergic agonist aceclidine, for treatment of presbyopia in adults. Aceclidine has been available in the EU for years for treatment of open-angle glaucoma.