Legal and Regulatory

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The US Food and Drug Administration (FDA) has granted approval for GlaxoSmithKline's biologics licence application (BLA) for Nucala...

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Pharmacy2U (P2U), the UK's largest NHS-approved online pharmacy, has been fined £130,000 by the government's Information Commissioner's Office...

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The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Pfizer's investigational antibody-drug conjugate (ADC)...

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Swiss biopharmaceutical firm Basilea Pharmaceutica has received approval from the European Commission for its antifungal isavuconazole to treat...

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Boehringer Ingelheim Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for Praxbind (idarucizumab) as...

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The UK's National Institute for Health and Care Excellence (NICE) has recommended Bristol-Myers Squibb's (BMS) daklinza (daclatasvir) to...

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The US Food and Drug Administration (FDA) has granted fast-track designation for Irish biopharmaceutical firm Shire's Cinryze (C1...

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GlaxoSmithKline (GSK) has submitted a regulatory application to the European Medicines Agency (EMA) seeking approval for its antiseptic...