FDA warning

News

Warning letter adds to Applied Tx run of bad news

Applied Therapeutics gets a warning letter from the FDA over a trial of rare disease drug govorestat, which was rejected by the agency last week.

News

FDA warns of genital gangrene risk with diabetes drug class

The US regulator released an official risk warning of a rare genital infection identified in 12 patients, including one fatality, after using SGLT2 class drugs for type 2 diabetes.

News

GSK ends decades-long hiatus in oral antibiotics for UTIs

The FDA has approved GSK's Blujepa, the first new-mechanism oral antibiotic for uncomplicated UTIs in nearly 30 years, after a priority review.

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Health Trends 2025: Reimagining What's Possible

Join the conversation, on Tuesday 28th January @ 10 am ET - 3 pm GMT - 4 pm CET, in our webinar sponsored by Syneos Health, entitled ‘Health Trends 2025: Reimagining What's Possibl

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