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FDA approves first new antibiotic for UTIs in nearly 30 years

On March 25, 2025, the U.S. Food and Drug Administration approved Blujepa , a new oral antibiotic developed by GSK, to treat uncomplicated urinary tract infections in females 12 and older.
Recurrent UTIs have become a growing concern due to increasing antibiotic resistance, with approximately half of all women experiencing a UTI in their lifetime and about 30% experiencing a recurrence after treatment.
Blujepa represents the first new class of oral antibiotics for UTIs in nearly three decades, offering a targeted mechanism of action that may reduce the likelihood of bacterial resistance compared to frontline antibiotics like nitrofurantoin, and performed as well as or better than nitrofurantoin in clinical trials.
Dr. Tony Wood, GSK's chief scientific officer, stated that Blujepa's approval is a crucial milestone, emphasizing its potential to provide another option for patients facing recurrent infections and rising antibiotic resistance.
Clinical trials involving over 3,000 women and teen girls showed that common side effects of Blujepa included diarrhea and nausea , while the US government's Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency partially funded Blujepa's development.

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The Hill

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FDA approves first new UTI drug in decades

The Food and Drug Administration (FDA) has approved a new drug for treating urinary tract infections (UTIs), the first such drug approved in decades and the first in a new class of medications. British pharmaceutical company GSK announced Tuesday that the FDA had approved its oral antibiotic Blujepa for treating uncomplicated urinary tract infections in…

2 days ago·Washington, United States

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Global News

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FDA approves new antibiotic to treat UTIs in females - National

The U.S. Food and Drug Administration on Tuesday approved GSK's drug for a common type of urinary tract infection (UTI) in women and adolescent girls.

2 days ago·Toronto, Canada

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Straight Arrow News

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FDA approves first new antibiotic to treat UTIs in nearly 3 decades

The FDA approved a new antibiotic to treat urinary tract infections in women and girls 12 and older. The company expects it to be available sometime in 2025. UTIs are becoming harder to treat as the bacteria that cause them become increasingly antibiotic-resistant. Nearly all bacteria that cause UTIs are resistant to at least one of the current medications used to treat the infections, and 8 in 10 are resistant to at least two. Full Story For th…

2 days ago

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KJRH

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FDA approves first new antibiotic treatment for UTIs in decades

A new antibiotic has been approved to treat urinary tract infections by the Food and Drug Administration for the first time in decades.Its an oral pill called Blujepa from the London-based biopharma company GSK.The company announced Tuesday that the FDA has approved its medication to treat uncomplicated UTIs in women and girls ages 12 and up.Its the most common type of UTI seen in women and more than half are likely to have at least one in their…

2 days ago

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abc 7 LA

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FDA approves new medication for urinary tract infections

The US Food and Drug Administration has approved a new type of antibiotic to treat urinary tract infections.

2 days ago·Los Angeles, United States

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biopharmadive.com

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FDA approves first-of-its-kind antibiotic from GSK

The drug is a needed new option for treating uncomplicated UTIs, a common infection that’s becoming harder to treat as rates of microbial resistance rise.

2 days ago

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