The FDA has approved tenapanor (Ibsrela - Ardelyx), a sodium/hydrogen exchanger 3 (NHE3) inhibitor, for twice-daily oral treatment of irritable bowel syndrome with constipation (IBS-C) in adults. Tenapanor is the first NHE3 inhibitor to become available in the US.

The FDA has expanded its Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to allow for their use in children as young as 6 months old. The Pfizer vaccine was previously authorized for use in persons ≥5 years old, and the Moderna vaccine was authorized for use in adults ≥18 years old.

The FDA has approved Airsupra (AstraZeneca), a metered-dose inhaler containing the short-acting beta₂-agonist (SABA) albuterol and the inhaled corticosteroid (ICS) budesonide, for use as needed for treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients ≥18 years old with asthma. Airsupra is the first combination of a SABA and an ICS to become available in the US. It is not approved for use as maintenance therapy.

The FDA has licensed new 2025-2026 formulations of the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax, mNEXSPIKE) and the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax (Nuvaxovid). The new formulations are indicated for use in all adults ≥65 years old and in persons 6 months (Spikevax), 5 years (Comirnaty), or 12 years (mNEXSPIKE, Nuvaxovid) through 64 years old who are at high risk for severe COVID-19 because of an underlying condition. An Emergency Use Authorization allowing administration of the Pfizer vaccine to...

The FDA has approved two antibiotics, gepotidacin (Blujepa — GSK) and zoliflodacin (Nuzolvence — Entasis), for oral treatment of uncomplicated urogenital gonorrhea in patients ≥12 years old. Gepotidacin is approved for use in persons weighing ≥45 kg who have limited or no alternative treatment options; it was approved in 2025 for treatment of uncomplicated urinary tract infection in females. Zoliflodacin is approved for use in persons weighing ≥35 kg. Neither drug is indicated for treatment of rectal or pharyngeal gonorrhea.

Many drugs, mostly azole derivatives, are marketed in the USA for topical treatment of vulvovaginal candidiasis. A single-dose, sustained-release formulation of butoconazole nitrate 2% cream (Gynazole 1) is the newest addition. Fluconazole (Diflucan) is approved for single-dose oral treatment.

Acetaminophen (paracetamol; Tylenol, and others) taken in overdosage can cause severe hepatic injury and death. Acetaminophen poisoning is treated with (N-)acetylcysteine. Available for many years in the US as a solution for inhalation therapy (Mucomyst, and others), it subsequently became available for oral use and was recently marketed in the US for intravenous (IV) use as Acetadote (Cumberland).

The FDA has approved 2 new treatments for castration-resistant (formerly called hormone-refractory) prostate cancer. Sipuleucel-T (Provenge – Dendreon) is the first immunotherapy approved for treatment of prostate cancer. Cabazitaxel (Jevtana – Sanofi-Aventis) is approved for second-line treatment of metastatic castration-resistant prostate cancer previously treated with docetaxel (Taxotere).

The FDA has approved a once-weekly extendedrelease formulation of exenatide (Bydureon – Amylin), an injectable glucagon-like peptide-1 (GLP-1) receptor agonist, for treatment of type 2 diabetes.

The FDA has approved two new oral kinase inhibitors for treatment of unresectable or metastatic melanoma: dabrafenib (Tafinlar – GSK) for melanomas with BRAF V600E mutations and trametinib (Mekinist – GSK) for melanomas with either BRAF V600E or V600K mutations. Dabrafenib is not recommended for patients with wild-type BRAF (BRAF-negative) melanoma, and trametinib is not recommended for patients who have received prior BRAF-inhibitor therapy.