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NEWS

GSK & Spero Therapeutics Report the US FDA Approval of Utebzi for Complicated Urinary Tract Infections (cUTIs)

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…
June 18, 2026

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Allecra Therapeutics
NEWS

The US FDA Approves Allecra Therapeutics’ Exblifep for the Treatment of Complicated Urinary Tract Infections (cUTIs) 

Shots:  The US FDA has granted approval to the company’s Exblifep for the treatment of complicated urinary tract infections (incl. pyelonephritis) patients (18yrs. & above) along with a 5-yr. marketing exclusivity extension until 2032  The approval was based on clinical data that showed the effectiveness of Exblifep against antimicrobial resistance in gram –ve bacteria, especially…
February 27, 2024

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VIEWPOINTS_James Graham_2023
VIEWPOINTS

James Graham, CEO of Recce Pharmaceuticals Shares Insights from the Expansion and Acceleration of Clinical Programs

Shots: James gave an overview of the timeline of Recce Pharmaceuticals' clinical programs with several significant data read-outs in 2022 and 2023 He emphasized the study design and results from the different infectious disease clinical and preclinical programs in its product portfolio The interview highlights how the development and commercialization of New Classes of Synthetic Anti-Infectives…
April 18, 2023

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