AstraZeneca’s Farxiga Label Includes, But Downplays, Bladder Cancer Risk
AstraZeneca’s SGLT-2 inhibitor Farxiga (dapagliflozin) finally clears FDA, and without a black box warning on bladder cancer risk – allowing the drug to compete with J&J’s first-to-market Invokana.
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On top of concerns about safety, which could present regulatory hurdles, bempedoic acid is likely to face a tougher competitive environment after the decline in PCSK9 inhibitor pricing.
FDA Warning On SGLT-2 Drugs Raises Specter Of Labeling Change
FAERS reports identify cases of diabetic ketoacidosis, ordinarily rare in type 2 diabetes, which were not associated with high blood sugar levels.
AstraZeneca, Flying Solo, Sees Momentum Take Off In Diabetes
The company launched three diabetes drugs in 2014, just after breaking off a joint venture with Bristol-Myers and taking over full control of the business. U.S. President Paul Hudson talked about the evolution of AstraZeneca’s diabetes business – and where it stands today – in a recent interview.