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RSS FeedPosted by Michael Wonder on 22 Nov 2021
Deciphera receives European Commission approval of Qinlock for the treatment of fourth-line gastro-intestinal stromal tumour
22 November 2021 - Qinlock significantly reduced the risk of disease progression or death by 85% and showed clinically meaningful overall ...
Posted by Michael Wonder on 22 Nov 2021
European Commission approves Roche’s Gavreto (pralsetinib) for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer
19 November 2021 - Gavreto is the first and only precision medicine approved in the EU for first-line treatment of people ...
Posted by Michael Wonder on 20 Nov 2021
Pfizer's Xeljanz (tofacitinib) receives marketing authorisation in the European Union for the treatment of active ankylosing spondylitis
18 November 2021 - Pfizer announced today that the European Commission has approved Xeljanz (tofacitinib) 5 mg twice daily for the ...
Posted by Michael Wonder on 17 Nov 2021
AbbVie expands immunology portfolio in the European Union with the European Commission approval of Skyrizi (risankizumab) for the treatment of adults with active psoriatic arthritis
17 November 2021 - Approval supported by data from two Phase 3 studies evaluating Skyrizi in psoriatic arthritis patients, KEEPsAKE-1 and ...
Posted by Michael Wonder on 17 Nov 2021
European Commission approves Nucala (mepolizumab) in three additional eosinophil-driven diseases
17 November 2021 - Approval for the first targeted treatment for eosinophilic granulomatosis with polyangiitis and the first anti-IL-5 biologic treatment ...
Posted by Michael Wonder on 15 Nov 2021
Celltrion’s monoclonal antibody treatment regdanvimab, approved by the European Commission for the treatment of COVID-19
14 November 2021 - The European Commission granted marketing authorisation for Celltrion’s regdanvimab following positive opinion by the EMA's CHMP last ...
Posted by Michael Wonder on 15 Nov 2021
Horizon Therapeutics receives CHMP positive opinion for Uplinza (inebilizumab) as a monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorder
12 November 2021 - CHMP recommendation based on positive results from N-MOmentum, the largest clinical trial ever conducted in NMOSD to ...
Posted by Michael Wonder on 15 Nov 2021
Ozempic 2 mg recommended for approval for the treatment of type 2 diabetes by the European Medicines Agency
12 November 2021 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion recommending a label ...
Posted by Michael Wonder on 15 Nov 2021
Wegovy recommended for approval for the treatment of obesity by the European regulatory authorities
11 November 2021 - Novo Nordisk today announced that the European Medicines Agency’s CHMP has adopted a positive opinion, recommending ...
Posted by Michael Wonder on 13 Nov 2021
Highlights from CHMP 8-11 November 2021 meeting
12 November 2021 - EMA’s CHMP recommended eleven medicines for approval at its November 2021 meeting. ...
Posted by Michael Wonder on 12 Nov 2021
First in class medicine recommended for treatment of rare blood vessel inflammation
12 November 2021 - EMA has recommended granting a marketing authorisation in the European Union for Tavneos (avacopan), a first in ...
Posted by Michael Wonder on 11 Nov 2021
COVID-19: EMA recommends authorisation of two monoclonal antibody medicines
11 November 2021 - EMA’s CHMP has recommended authorising Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab) for COVID-19. ...
Posted by Michael Wonder on 08 Nov 2021
SMC - November 2021 decisions
8 November 2021 - The Scottish Medicines Consortium which advises on newly licensed medicines for use by NHSScotland has published ...
Posted by Michael Wonder on 28 Oct 2021
EMA nod for excessive daytime sleepiness med Ozawade
28 October 2021 - The EMA has approved Bioprojet’s Ozawade (pitolisant) for the treatment of excessive daytime sleepiness associated with ...
Posted by Michael Wonder on 25 Oct 2021
Spikevax: EMA recommendation on booster
25 October 2021 - The EMA’s CHMP has concluded that a booster dose of the COVID-19 vaccine Spikevax (from Moderna) ...