Legal and Regulatory

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Ireland-based Alkermes has received approval from the US Food and Drug Administration (FDA) for Aristada (aripiprazole lauroxil) extended-release...

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The US Food and Drug Administration (FDA) has accepted Novartis company Sandoz's biologics licence application (BLA) under the...

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The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Israel-based Teva Pharmaceutical Industries' once-daily...

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The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion...

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US-based Turing Pharmaceuticals CEO Martin Shkreli has reportedly agreed to cut the price of a toxoplasmosis drug Daraprim...

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Taiho Oncology has received approval from the US Food and Drug Administration (FDA) for Lonsurf (trifluridine and tipiracil)...