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Glassia

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FDA grants surprise OK to Sarepta’s DMD therapy after earlier rejection

Initially had concerns about infection risks and kidney toxicity

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Biogen defends aducanumab filing plan amid scepticism

A new look at pivotal trial data described as hard-to-interpret

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J&J to FDA: there really is no asbestos in Baby Powder

Rejects findings that product contained 'sub-trace' levels of asbestos

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Biogen scores mid-stage trial win for lupus drug BIIB059

Last approved treatment for Lupus was GSK's Benlysta in 2011

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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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Pfizer, Flynn face reinstatement of £90m CMA fine

Facing penalty for dramatic price hikes of an epilepsy drug

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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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Pfizer’s Ibrance scores second-line breast cancer approval via NICE’s Cancer Drugs Fund

Around 3,200 women in England could be eligible for treatment

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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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