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RSS FeedPosted by Michael Wonder on 28 Aug 2021
Incyte and MorphoSys announce the European Commission approval of Minjuvi (tafasitamab) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma
26 August 2021 - In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL. ...
Posted by Michael Wonder on 24 Aug 2021
European Commission approves Rinvoq (upadacitinib) as first JAK inhibitor in the European Union for the treatment of both adults and adolescents with moderate to severe atopic dermatitis
24 August 2021 - Approval supported by data from one of the largest registrational Phase 3 programs in atopic dermatitis evaluating ...
Posted by Michael Wonder on 24 Aug 2021
UCB announces European Commission approval of Bimzelx (bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis
24 August 2021 - The approval in the European Union represents the first marketing authorisation for UCB’s new psoriasis treatment worldwide. ...
Posted by Michael Wonder on 23 Aug 2021
Europe has its first Lucentis biosimilar, Samsung Bioepis’ Byooviz
23 August 2021 - Novartis and Roche’s big-selling eye drug Lucentis has its first biosimilar competitor in Europe, after the ...
Posted by Michael Wonder on 23 Aug 2021
Xeljanz (tofacitinib citrate) receives marketing authorisation in the European Union for the treatment of active polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis
20 August 2021 - Pfizer announced today that the European Commission has approved Xeljanz (tofacitinib) for the treatment of active polyarticular ...
Posted by Michael Wonder on 20 Aug 2021
Bristol Myers Squibb receives European Commission approval for Abecma (idecabtagene vicleucel), the first anti-BCMA CAR T cell therapy for relapsed and refractory multiple myeloma
19 August 2021 - Abecma represents the only cell therapy approved for multiple myeloma. ...
Posted by Michael Wonder on 20 Aug 2021
Astellas receives European Commission approval for first in class Evrenzo (roxadustat) for adult patients with symptomatic anaemia of chronic kidney disease
20 August 2021 - Roxadustat is the first orally administered hypoxia-inducible factor prolyl hydroxylase inhibitor available for adult patients with anaemia ...
Posted by Michael Wonder on 09 Aug 2021
Forxiga approved in the EU for the treatment of chronic kidney disease in patients with and without type 2 diabetes mellitus
9 August 2021 - Approval based on unprecedented DAPA-CKD Phase 3 data is the most significant advancement in chronic kidney ...
Posted by Michael Wonder on 03 Aug 2021
Amicus Therapeutics announces European Commission approval of Galafold (migalastat) for adolescents with Fabry disease
2 August 2021 - Galafold is the first and only oral therapy approved in the EU for the long-term treatment of ...
Posted by Michael Wonder on 02 Aug 2021
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) as adjuvant treatment for oesophageal or gastro-oesophageal junction cancer patients with residual pathologic disease following chemoradiotherapy
30 July 2021 - Approval is based on Phase 3 results from the CheckMate-577 trial. ...
Posted by Michael Wonder on 26 Jul 2021
Rhythm Pharmaceuticals announces European Commission authorisation of Imcivree (setmelanotide) for the treatment of obesity and control of hunger associated with POMC, PCSK1 and LEPR deficiency
23 July 2021 - First ever authorised treatment option in the European Union for these rare genetic diseases of obesity. ...
Posted by Michael Wonder on 26 Jul 2021
Ultomiris recommended for approval in the EU by CHMP for children and adolescents with paroxysmal nocturnal haemoglobinuria
26 July 2021 - Opinion based on results from Ultomiris Phase 3 trial that showed an established efficacy and safety ...
Posted by Michael Wonder on 25 Jul 2021
EMA CHMP adopts positive opinion recommending authorisation for the use of the Moderna COVID-19 Vaccine in adolescents (12-17 years of age) in the European Union
23 July 2021 - . 23, 2021-- Moderna today announced that the EMA's CHMP adopted a positive opinion recommending marketing authorisation ...
Posted by Michael Wonder on 25 Jul 2021
Highlights from the 19-22 July CHMP meeting
23 July 2021 - Two new medicines recommended for approval. ...
Posted by Michael Wonder on 24 Jul 2021
Kyowa Kirin provides update on application for marketing authorisation of istradefylline in Europe for the treatment of ‘OFF’ episodes in people living with Parkinson’s
23 July 2021 - Kyowa Kirin today announced that the EMA's CHMP issued a negative opinion for istradefylline as an add-on ...