The companies resubmitted SGLT2 inihibitor empagliflozen for FDA review. The EC approved the drug in May.
Novartis says the FDA wants more serelaxin efficacy data.
The firm has vowed to appeal an FDA rejection that otherwise complicates its bid to expand in multiple sclerosis.
The FDA wants more data for the proposed canagliflozin-metformin medication mix.
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