FDA approves olutasidenib for relapsed or refractory acute myeloid leukaemia with a susceptible IDH1 mutation

1 December 2022 - Today, the FDA approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid ...

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Livtencity (maribavir) receives positive CADTH recommendation for adults with post-transplant cytomegalovirus infection

1 December 2022 - The conditions for the positive recommendation is supported by the findings of the Phase 3 SOLSTICE ...

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Scynexis announces FDA approval of second indication for Brexafemme (ibrexafungerp) for reduction in incidence of recurrent vulvovaginal candidiasis

1 December 2022 - Approval is based on pivotal Phase 3 CANDLE data demonstrating statistically significant superiority of ibrexafungerp over ...

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Aurinia announces the Great Britain marketing authorisation of Lupkynis (voclosporin) for the treatment of lupus nephritis

30 November 2022 - MHRA Approval follows European Commission marketing authorisation of Lupkynis to treat adults with active lupus nephritis in ...

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Reimbursed access to Bylvay (odevixibat) approved in France for patients with PFIC 1 & 2

30 November 2022 - Albireo Pharma today announced that the Committee Economic Health Products has approved reimbursed access to Bylvay (odevixibat) ...

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Cemiplimab for the first-line treatment of patients wth advanced or metastatic PD-L1 positive non-small-cell lung cancer

1 December 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...

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FDA approves first faecal microbiota product

30 November 2022 - Today, the US FDA approved Rebyota, the first faecal microbiota product approved by the agency.  ...

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European Commission grants expanded marketing authorisation for Gilead’s Biktarvy for the treatment of HIV in paediatric populations

29 November 2022 - European Commission authorises a low dose tablet for HIV treatment in virologically suppressed children at least two ...

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Mepolizumab for the treatment of patients with severe chronic rhinosinusitis with nasal polyps

29 November 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...

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Leo Pharma’s Adtralza approved by MHRA, EC for adolescent atopic dermatitis

29 November 2022 - The MHRA and the European Commission have approved a change to the terms of the marketing ...

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Capstone announces authorisation of biosimilar human insulin for IV infusion in Canada and EU

29 November 2022 -  Capstone announced today that a biosimilar version of human insulin received authorisation from the EMA's CHMP ...

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Roche withdraws Tecentriq from US bladder cancer indication

29 November 2022 - Roche has voluntarily withdrawn the US indication of Tecentriq for treating a form of bladder cancer ...

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Voclosporin with immunosuppressives for the treatment of patients with lupus nephritis

29 November 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...

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Mepolizumab for the treatment of patients with severe hypereosinophilic syndrome

29 November 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...

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Mepolizumab for the treatment of patients with eosinophilic granulomatosis with polyangiitis

29 November 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...

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