From Crohn disease to uncomplicated urinary tract infections and beyond, the FDA issued several high-impact drug approvals last month.

The FDA has approved Blujepa (gepotidacin) for the treatment of female patients 12 years of age and older weighing at least 40kg with uncomplicated UTI.

coli. It is approved for women and girls aged 12 and older. What sets Blujepa apart is its innovative mechanism of action, which targets bacteria differently from older antibiotics like nitrofurantoin ...

Fact checked by Nick Blackmer The Food and Drug Administration (FDA) recently approved a new antibiotic to treat urinary tract infections (UTIs). The drug gepotidacin, which will be sold under the ...

Guangdong Provincial Key Laboratory of Information Photonics Technology, Guangdong Provincial Key Laboratory of Functional Soft Condensed Matter, School of Material and Energy, Guangdong University of ...

Study participants were randomly assigned to receive gepotidacin 1500mg twice daily or nitrofurantoin 100mg twice daily for 5 days. The primary endpoint for both trials was the combined clinical ...

Blujepa, which is made by the British pharmaceutical company GSK plc, is approved for the treatment of women and children over the age of 12 with uncomplicated UTIs caused by bacteria including E.

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

这两项试验中，Blujepa在治疗患uUTI的成年女性（≥40 kg）及青少年患者（≥12岁、≥40 kg）时，与当前标准治疗之一nitrofurantoin相比具有非劣效性。

The FDA approval is based on late-stage data, which shows that GSK's Blujepa is at least as effective as a leading standard treatment for uncomplicated UTIs.

The approval was based on data from two late-stage trials showing the drug was superior to nitrofurantoin, the standard-of-care medication introduced in the 1950s. In one of GSK’s studies, gepotidacin ...