The US FDA New Drug Approvals in June 2026 

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.  Bayer Reports the US FDA Approval of Ambelvist to Enhance MRI Detection of Lesions                  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)  GSK & Spero Therapeutics Report the US FDA Approval of Utebzi for Complicated Urinary Tract Infections (cUTIs)                  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  Viridian Therapeutics Reports the US FDA Approval of Lumvoa (veligrotug-vvze) for Thyroid Eye Disease                  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  The post The US FDA New Drug Approvals in June 2026  appeared first on PharmaShots.