Blog
RSS FeedPosted by Michael Wonder on 02 Dec 2022
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 ...
Posted by Michael Wonder on 01 Dec 2022
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 ...
Posted by Michael Wonder on 01 Dec 2022
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 ...
Posted by Michael Wonder on 01 Dec 2022
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 ...
Posted by Michael Wonder on 01 Dec 2022
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) ...
Posted by Michael Wonder on 01 Dec 2022
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 ...
Posted by Michael Wonder on 01 Dec 2022
FDA approves first faecal microbiota product
30 November 2022 - Today, the US FDA approved Rebyota, the first faecal microbiota product approved by the agency. ...
Posted by Michael Wonder on 30 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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 ...