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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Turalio: Why The EU Said No To The US-Approved Drug
Not everyone reviewing Daiichi Sankyo’s EU marketing application for Turalio agreed that the potential tenosynovial giant cell tumor treatment shouldn't be approved.
SynOx Seeks Solution For TGCT With Roche Antibody
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.
Keeping Track: Turalio, Nubeqa And Accrufer Mark Trio Of Novel Drug Approvals
The latest drug development news and highlights from our US FDA Performance Tracker.