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tolvaptan

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Amarin files fish oil-based heart drug Vascepa in Europe

FDA verdict is also due for expanded use of the drug

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Y-mAbs files breakthrough neuroblastoma drug in US

Rare cancer type mostly affects babies and young children

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Diurnal files adrenal insufficiency drug Alkindi in US

Could become only treatment for children with the condition

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Incyte claims FDA priority review for bile duct cancer drug

Significant need for new therapies in hard-to-treat cancer type

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FDA backs GBT’s sickle cell drug Oxbryta

Second new treatment for blood disorder to be approved this year

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Roche scores FDA priority review for risdiplam in SMA

Potential rival to Novartis’ Zolgensma and Biogen’s Spinraza

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FDA clears SK Life Science’s anti-epileptic drug Xcopri

Significantly reduced the frequency of seizures at all doses studied

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FDA clears Alnylam’s second RNAi drug for rare disease

Second drug in the class to be cleared by regulatory authority

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BeiGene bags FDA approval for first product Brukinsa in lymphoma

Also the first approval for a Chinese-developed cancer drug in US

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Amarin wins FDA advisory nod for Vascepa cardiovascular expansion

Approval likely for fish-oil derived drug following speedy review

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Otsuka presses on with Alzheimer’s agitation drug

Surprise announcement comes on the heels of phase 3 trial fail

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Aveo’s tivozanib is knocked back by FDA once again

Company says it will delay any regulatory filing until first quarter next year

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