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Astellas Pharma announced it has received an action letter from the FDA regarding the company's new drug application (NDA) for its once-daily immunosuppressant FK506 modified-release formulation (tacrolimus).
Wyeth Pharmaceuticals announced it has received an approvable letter from the FDA for Pristiq (desvenlafaxine succinate), a serotonin-norepinephrine reuptake inhibitor, as a treatment for adults with major depressive disorder.
Callisto Pharmaceuticals has announced the publication of data on a Degrasyn (STAT3 pathway inhibitor) drug candidate showing promise as a therapeutic agent to treat malignant gliomas.
Innocoll announced that the FDA has approved its investigational new drug application to conduct a Phase II study for CollaRx Gentamicin as a topical antibiotic treatment for mildly infected diabetic foot ulcers.
Roche has announced the OPTION trial, the first international Phase III study of Actemra outside of Japan, successfully met its primary endpoint in patients with moderate to severe rheumatoid arthritis (RA) who had an inadequate response to methotrexate, a current standard of care.