FDA warning

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ImmunityBio warned by FDA over 'misleading' Anktiva content

The FDA has sent a warning letter to ImmunityBio over "false and misleading" comments made by executive chair, billionaire Patrick Soon-Shiong.

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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.

ImmunityBio warned by FDA over 'misleading' Anktiva content

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

GLP-1s drive Lilly's Q1, but it's reticent on oral launch

Discover a new era of healthcare panel engagement: Grounded ...

FDA warning

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