Complete Response Letter

Lilly, BI resubmit diabetes medication

The companies resubmitted SGLT2 inihibitor empagliflozen for FDA review. The EC approved the drug in May.

FDA says no to Novartis heart drug

FDA says no to Novartis heart drug


Novartis says the FDA wants more serelaxin efficacy data.

Lemtrada US rejection snarls Sanofi

Lemtrada US rejection snarls Sanofi


The firm has vowed to appeal an FDA rejection that otherwise complicates its bid to expand in multiple sclerosis.

Janssen gets diabetes CRL

The FDA wants more data for the proposed canagliflozin-metformin medication mix.

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