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simvastatin

- PMLiVE

Amarin files fish oil-based heart drug Vascepa in Europe

FDA verdict is also due for expanded use of the drug

- PMLiVE

Y-mAbs files breakthrough neuroblastoma drug in US

Rare cancer type mostly affects babies and young children

- PMLiVE

Diurnal files adrenal insufficiency drug Alkindi in US

Could become only treatment for children with the condition

- PMLiVE

Incyte claims FDA priority review for bile duct cancer drug

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

- PMLiVE

Merck’s Keytruda picks up third approval for NSCLC in China

New indication as a first-line treatment in combination with chemotherapy

- PMLiVE

FDA backs GBT’s sickle cell drug Oxbryta

Second new treatment for blood disorder to be approved this year

- PMLiVE

Roche scores FDA priority review for risdiplam in SMA

Potential rival to Novartis’ Zolgensma and Biogen’s Spinraza

- PMLiVE

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

Significantly reduced the frequency of seizures at all doses studied

- PMLiVE

MSD’s Keytruda scores another EU okay, in head and neck cancer

First anti-PD-1 drug to improve overall survival in first-line setting

- PMLiVE

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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Bayer, Merck’s high-risk heart failure drug comes good in phase 3

Significantly reduced the risk of hospitalisation or cardiovascular death

- PMLiVE

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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