Celgene shaken again after the FDA kicks back their marketing application on blockbuster hopeful ozanimod
Celgene has been slammed with a refuse-to-file letter from the FDA for ozanimod, the biggest late-stage drug it has in the pipeline.
The biotech reported after the market closed Tuesday that the RTF came through because the FDA determined “that the nonclinical and clinical pharmacology sections in the NDA were insufficient to permit a complete review” for multiple sclerosis.
That’s going to hurt — bad.
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