FDA warning

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Novo rapped by FDA for not reporting drug adverse effects

Novo Nordisk has been sent a warning letter from the FDA for violations of postmarketing adverse drug experience (PADE) regulations.

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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.

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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.

Novo rapped by FDA for not reporting drug adverse effects

Warning letter adds to Applied Tx run of bad news

FDA warns of genital gangrene risk with diabetes drug class

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