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 approved sotatercept-csrk (Winrevair – Merck), a first-in-class activin signaling inhibitor, to increase exercise capacity, improve WHO functional class, and reduce the risk of clinical worsening events in adults with WHO Group 1 pulmonary arterial hypertension (PAH).

The FDA has approved rezafungin (Rezzayo – Cidara/Melinta), an intravenous echinocandin antifungal, for once-weekly treatment of candidemia and invasive candidiasis (IC) in adults with limited or no alternative options. It is the first new drug to become available in the US in more than 15 years for treatment of systemic Candida infections.

Nemolizumab (Nemluvio – Galderma), a subcutaneously injected interleukin-31 (IL-31) receptor antagonist, has been approved by the FDA for use in combination with topical corticosteroids and/or calcineurin inhibitors for treatment of moderate to severe atopic dermatitis in patients ≥12 years old whose disease is not adequately controlled with topical prescription drugs. It is the first IL-31 receptor antagonist to be approved in the US for this indication. Nemolizumab was approved earlier for treatment of prurigo nodularis in adults.

The FDA has approved Xifyrm (Azurity) and Qamzova (Nanjing Delova), two new intravenous (IV) formulations of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam, for use alone or in combination with non-NSAID analgesics for treatment of moderate to severe pain in adults. Anjeso, the first IV formulation of meloxicam, was discontinued in 2022 for commercial reasons.

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 Mavyret (Abbvie) and Vosevi (Gilead), two new fixed-dose combinations of direct-acting antiviral (DAA) drugs, for treatment of chronic hepatitis C virus (HCV) infection caused by any of the six major HCV genotypes in patients without cirrhosis or with compensated cirrhosis. Both are approved for use in treatment-experienced patients. Mavyret is also approved for treatment-naive patients.

Patients with seasonal allergies often experience nasal itching and congestion, sneezing, rhinorrhea, and itchy, watery eyes. Oral, intranasal, and ophthalmic preparations are widely available over the counter (OTC) for relief of symptoms. Prescription products for management of allergic rhinitis and allergic conjunctivitis are reviewed separately.

Cannabis (marijuana) contains more than 60 pharmacologically active cannabinoids; delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) are the best known. THC is the main psychoactive constituent of cannabis. CBD, unlike THC, does not produce intoxication or euphoria.

The oral sphingosine 1-phosphate (S1P) receptor modulator ozanimod (Zeposia – Bristol Myers Squibb) has been approved by the FDA for treatment of adults with moderately to severely active ulcerative colitis. It is the first S1P receptor modulator to be approved for treatment of ulcerative colitis. Ozanimod was approved in March 2020 for use in adults with relapsing forms of multiple sclerosis.