Daiichi Must Follow Turalio Patients For 10 Years To Assess Liver Safety
As the US FDA suggested during its advisory committee review, a long-term safety study is among the postmarketing commitments for the tenosynovial giant cell tumor treatment.
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Not everyone reviewing Daiichi Sankyo’s EU marketing application for Turalio agreed that the potential tenosynovial giant cell tumor treatment shouldn't be approved.
The UK's Celleron has attracted a "blue chip suite of investors" to an Irish-domiciled spin-off based on the potential of Roche-developed emactuzumab for TGCT, a debilitating orphan disease that causes joint damage and has limited clinical options.
The latest drug development news and highlights from our US FDA Performance Tracker.