Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in people ages 12 and older who have at least one F508del mutation

18 June 2021 - Approximately 1,100 F/MF patients now eligible for a CFTR modulator to treat the underlying cause of their ...

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U.S. FDA approves new formulation of Epclusa, expanding paediatric indication to treat children ages 3 and older with chronic hepatitis C

10 June 2021 - Gilead Sciences announced today that the U.S. FDA has approved an expansion of the pediatric indication of ...

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Vertex announces U.S. FDA approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 with certain mutations

9 June 2021 - With this approval approximately 1,500 children with one minimal function mutation and one F508del mutation have a ...

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Lannett announces FDA acceptance, as a priority original ANDA, of the generic Advair Diskus filing

1 June 2021 - Lannett  today announced the U.S. FDA has accepted the abbreviated new drug application for fluticasone propionate and ...

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Alkermes announces FDA approval of Lybalvi for the treatment of schizophrenia and bipolar I disorder

1 June 2021 - Commercial launch planned for fourth quarter 2021. ...

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Positive CHMP opinion for Ryeqo (relugolix combination tablet)

21 May 2021 - Gedeon Richter announces that the CHMP of the EMA has adopted a positive opinion recommending approval of ...

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EMA, MHRA to review Vertex' Kaftrio for children with cystic fibrosis

20 May 2021 - The EMA and the MHRA have validated Vertex' applications to expand the scope of its cystic ...

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New Zealanders living with cystic fibrosis wait for 'life changing' drug

16 May 2021 - Edward Lee​ and Reese Robertson​ both have cystic fibrosis. ...

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Heron Therapeutics announces U.S. FDA approval of Zynrelef for the management of post-operative pain for up to 72 hours

13 May 2021 - Full U.S. commercial launch of Zynrelef is planned for July 2021. ...

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MHRA approves label extension for Vertex’s Kaftrio combo

11 May 2021 - The UK MHRA has approved a label extension for Vertex’s cystic fibrosis treatment Kaftrio in combination ...

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Families plead for PBS listing for ‘life-saving’ cystic fibrosis drug

8 May 2021 - A new drug is being hailed as a “game-changer” for cystic fibrosis sufferers as the government is ...

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The price of a Vertex cystic fibrosis treatment stirs anger in Australia

23 April 2021 - The latest dustup over the cost of cystic fibrosis medicines sold by Vertex Pharmaceuticals is taking ...

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Aerie Pharmaceuticals receives marketing authorisation of Roclanda 50 mcg/mL + 200 mcg/mL solution eye drops (latanoprost + netarsudil) in Great Britain

19 April 2021 - Aerie Pharmaceuticals today announced that Roclanda 50 mcg/mL + 200 mcg/mL solution eye drops (latanoprost + netarsudil) ...

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Mayne Pharma and Mithra announce FDA approval of new oral contraceptive Estelle

15 April 2021 - Mayne Pharma Group and Mithra Pharmaceuticals are very pleased to announce that the US FDA has approved ...

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Jazz Pharmaceuticals announces FDA acceptance and priority review of supplemental new drug application for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in idiopathic hypersomnia

12 April 2021 - Final FDA decision anticipated by 12 August. ...

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