Shots:
- The US FDA approved three notable therapies in June 2026, spanning diagnostic imaging, infectious diseases, and ophthalmology, highlighting continued progress in precision diagnostics, antimicrobial innovation, and rare disease treatment.
- Key approvals included Ambelvist (enhanced MRI detection of lesions), Utebzi (complicated urinary tract infections, including pyelonephritis), and Lumvoa (thyroid eye disease), expanding treatment and diagnostic options for patients with diverse clinical needs.
- Overall, June 2026 reflected the FDA’s commitment to advancing innovative imaging agents, addressing antimicrobial resistance, and accelerating therapies for rare and specialty diseases to improve patient care and clinical outcomes.
Company: Bayer
Product: Ambelvist
Active Ingredient: Gadoquatrane
Disease: Enhance MRI Detection of Lesions
Date: Jun 12, 2026
Shots:
- The US FDA has approved Ambelvist (gadoquatrane) for contrast-enhanced MRI to detect lesions with abnormal vascularity in the CNS and other body regions in adults and pediatric patients, including term neonates
- Approval was supported by the global P-III (QUANTI) studies, which demonstrated that Ambelvist improved lesion visualization at a lower gadolinium dose (0.04 mmol Gd/kg) while providing diagnostic performance comparable to conventional macrocyclic GBCAs dosed at 0.1 mmol Gd/kg. Its safety and efficacy were established in both adults and pediatric patients, including term neonates, supported by clinical, pharmacokinetic, and safety data from 93 pediatric patients (Aged:28 days to <18 yrs)
- Ambelvist is a gadolinium-based contrast agent indicated for contrast-enhanced MRI in adults and pediatric patients, including term neonates, to detect and visualize lesions with abnormal vascularity in the CNS (brain, spine, and associated tissues) and non-CNS body regions (head and neck, thorax, abdomen, pelvis, and musculoskeletal system)
Company: GSK & Spero Therapeutics
Product: Utebzi
Active Ingredient: Tebipenem Pivoxil
Disease: Complicated Urinary Tract Infections
Date: Jun 17, 2026
Shots:
- The US FDA has approved Utebzi (tebipenem pivoxil; 600mg, PO, Q6H) for the treatment of cUTIs incl. pyelonephritis, in adults who have limited or no alternative oral treatment options, with launch expected by the end of 2026
- Approval was supported by the P-III (PIVOT-PO) trial demonstrating that Utebzi was non-inferior to IV imipenem-cilastatin in hospitalized pts with cUTI, incl. pyelonephritis. At the test-of-cure visit, the ORR was 58.5% (261/446) vs 60.2% (291/483)
- In 2022, GSK & Spero entered into an exclusive licence agreement for Utebzi, granting GSK a licence to develop & commercialise it in all countries except Japan & certain other Asian countries
Company: Viridian Therapeutics
Product: Lumvoa
Active Ingredient: Veligrotug-vvze
Disease: Thyroid Eye Disease
Date: Jun 26, 2026
Shots:
- The US FDA has approved Lumvoa (veligrotug-vvze) for the treatment of thyroid eye disease (TED), with immediate launch planned across the US. Also, SC elegrobart BLA filing for TED on track for Q1’27
- Approval was granted under FDA Priority Review & supported by the P-III THRIVE (active TED) & THRIVE-2 (chronic TED) trials, which met their respective 1 & 2EPs, showing improvements at Wk. 15 across all of the key signs & symptoms of TED
- Lumvoa demonstrated rapid clinical benefit, reducing proptosis as early as Wk. 3 & significantly improving both diplopia response & complete resolution in active and chronic TED
