FDA approvals - June 2026

The FDA cleared three novel drugs in June across diagnostic imaging, infectious disease, and ophthalmology. Each enters a field with an established competitor.

Ambelvist: Bayer lowers the gadolinium dose in MRI contrast

On June 12, the FDA approved Ambelvist (gadoquatrane) from Bayer, an intravenous contrast agent for MRI of the central nervous system and the rest of the body in adults and children, including term neonates. The selling point is dose. Bayer says it is the lowest-dose macrocyclic gadolinium contrast agent approved in the U.S.

Gadoquatrane is a tetrameric macrocyclic complex that binds four gadolinium centers to a single molecule. That lets it work at 0.01 mmol per kilogram and deliver 0.04 mmol of gadolinium per kilogram, where standard macrocyclic agents deliver 0.1 and gadopiclenol 0.05.

Two crossover trials gave each patient Ambelvist and a comparator agent between two and 14 days apart, with 305 patients in the central nervous system study and 410 in the body study. Blinded readers scored the contrast-enhanced images above the unenhanced ones. The label describes scores against existing agents as similar, on a descriptive basis. A boxed warning covers nephrogenic systemic fibrosis and intrathecal use.

Utebzi: GSK takes a carbapenem-class antibiotic oral in complicated urinary infections

On June 17, GSK won approval for Utebzi (tebipenem pivoxil), an oral antibiotic for adults with complicated urinary tract infections, including pyelonephritis, who have limited or no alternative oral treatment options. GSK describes it as the first and only oral carbapenem approved in the U.S., and says carbapenems were until now available only intravenously.

Tebipenem pivoxil is a prodrug of tebipenem, which the label classes as a penem antibacterial. GSK licensed it from Spero Therapeutics, which shared development, and has since taken over the application.

PIVOT-PO enrolled 1,690 hospitalized patients and compared Utebzi 600 mg every six hours with intravenous imipenem-cilastatin. Among the 929 patients with a qualifying pathogen at baseline, the composite of clinical cure and microbiological response was 58.5 percent on Utebzi and 60.2 percent on the comparator, which met non-inferiority. In the small subgroup with bacteremia at baseline the rates were 40.6 percent (13 of 32 patients) and 61.8 percent (21 of 34). Warnings include hypersensitivity, seizures, and Clostridioides difficile infection.

Lumvoa: Viridian gains a thyroid eye disease label covering active and chronic disease

Closing the month on June 26, Viridian Therapeutics gained approval for Lumvoa (veligrotug-vvze), an intravenous antibody for thyroid eye disease. The label does not restrict use by disease activity or duration. Teprotumumab, also an IGF-1R antibody, was approved for the disease in 2020.

Veligrotug is a humanized IgG1 antibody against IGF-1R that blocks ligand-induced receptor autophosphorylation. The label states that its mechanism in thyroid eye disease has not been fully characterized.

Two trials read out at week 15. In active disease, 70 percent of 75 patients on Lumvoa met the proptosis responder definition against 5 percent of 38 on placebo. In chronic disease the rates were 57 percent of 125 patients against 8 percent of 63. Diplopia resolved in 49 percent against 12 percent in the active trial and 32 percent against 14 percent in the chronic one. The label carries a warning for hearing impairment, which is among the reactions reported in 5 percent or more of patients.

The Strategic Brief

Utebzi is the approval with the widest practical consequence. An oral carbapenem changes where some complicated infections can be treated, within a label reserved for patients with limited or no other oral choices.

Ambelvist competes on dose. Its trials showed contrast against no contrast, and the label's comparison with existing agents is descriptive.

Lumvoa enters a market that teprotumumab opened, with a label that covers active and chronic disease alike.

Sources

Ambelvist: FDA prescribing information; Drugs@FDA, NDA 219627; Onyx coverage.

Utebzi: FDA prescribing information; Drugs@FDA, NDA 215960; Onyx coverage.

Lumvoa: FDA prescribing information; Drugs@FDA, BLA 761530; Onyx coverage.