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FDA Approves SYMDEKO (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene

Vertex Pharmaceuticals Incorporated announced on Feb 12, 2018, that the U.S. Food and Drug Administration (FDA) approved SYMDEKO™ (tezacaftor/ivacaftor and ivacaftor) for treating the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation in the…

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U.S. Food and Drug Administration Approves Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV-1 Infection

On Feb. 7, 2018-- Gilead Sciences, Inc announced that the U.S. Food and Drug Administration (FDA) has approved Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. Biktarvy combines the novel, unboosted integrase strand…

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Hizentra (human normal immunoglobulin (SCIg)) – new indication Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) (inflammatory disease of the nerves)

On 25 January 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Hizentra. The marketing authorisation holder for this medicinal product is CSL Behring GmbH. The CHMP adopted a new indication as follows: “Immunomodulatory therapy…

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Steglatro, for the treatment of type 2 diabetes

On 25 January 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Steglatro, intended for the treatment of type 2 diabetes. The applicant for this medicinal product is Merck Sharp & Dohme…

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Shingrix, for prophylaxis of herpes zoster

On 25 January 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Shingrix, intended for prophylaxis of herpes zoster. The applicant for this medicinal product is GlaxoSmithkline Biologicals SA. Shingrix will be…

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