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RSS FeedPosted by Michael Wonder on 25 Jul 2022
Aurinia announces positive CHMP opinion for Lupkynis (voclosporin) for the treatment of adults with active lupus nephritis in Europe
22 July 2022 - Positive CHMP opinion is based on a comprehensive submission including data from the pivotal AURORA efficacy study ...
Posted by Michael Wonder on 24 Jul 2022
Rhythm Pharmaceuticals receives positive CHMP opinion for Imcivree (setmelanotide) for the treatment of obesity and control of hunger in patients with Bardet-Biedl syndrome
European Commission decision anticipated in fourth quarter of 2022. ...
Posted by Michael Wonder on 24 Jul 2022
CHMP recommends EU approval of Roche’s Vabysmo, the first bispecific antibody for the eye, for two leading causes of vision loss
22 July 2022 - The CHMP recommendation is based on results across four Phase 3 studies: TENAYA and LUCERNE in neovascular age-related ...
Posted by Michael Wonder on 23 Jul 2022
CHMP adopts positive opinion recommending Veklury (remdesivir) receive full marketing authorisation for the treatment of patients with COVID-19
22 July 2022 - If Granted by the European Commission, Veklury will become the only direct-acting antiviral with full marketing authorisation ...
Posted by Michael Wonder on 23 Jul 2022
EMA CHMP recommends use of the Moderna COVID-19 booster in adolescents (12-17 Years) in the European Union
22 July 2022 - Moderna today announced that the EMA's CHMP has adopted a positive opinion recommending a variation to ...
Posted by Michael Wonder on 23 Jul 2022
Kite’s CAR T-cell therapy Tecartus receives positive CHMP opinion in relapsed or refractory acute lymphoblastic leukaemia
22 July 2022 - Tecartus (brexucabtagene autoleucel) first and only CAR T in Europe to receive positive CHMP opinion to ...
Posted by Michael Wonder on 23 Jul 2022
Bristol Myers Squibb receives positive CHMP opinion recommending approval for LAG-3-blocking antibody combination Opdualag (nivolumab and relatlimab) for treatment of patients with unresectable or metastatic melanoma
22 July 2022 - Recommendation based on results from the Phase 2/3 RELATIVITY-047 trial, in which the fixed-dose combination of the ...
Posted by Michael Wonder on 23 Jul 2022
Alnylam receives positive CHMP opinion for vutrisiran for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy
22 July 2022 - Positive opinion based on HELIOS-A Phase 3 study. ...
Posted by Michael Wonder on 23 Jul 2022
New medicine for multiple myeloma patients with limited treatment options
22 July 2022 - The EMA has recommended a conditional marketing authorisation in the European Union for Tecvayli (teclistamab) for ...
Posted by Michael Wonder on 23 Jul 2022
EMA recommends approval of Imvanex for the prevention of monkeypox disease
22 July 2022 - The EMA’s has recommended extending the indication of the smallpox vaccine Imvanex to include protecting adults ...
Posted by Michael Wonder on 22 Jul 2022
Upstaza granted marketing authorisation by European Commission as first disease-modifying treatment for AADC deficiency
20 July 2022 - PTC Therapeutics to launch first gene therapy directly administered into the brain. ...
Posted by Michael Wonder on 21 Jul 2022
Karyopharm and Menarini receive full marketing authorisation from the European Commission for Nexpovio (selinexor) for the treatment of patients with multiple myeloma after at least one prior therapy
21 July 2022 - Based on Results from Phase 3 BOSTON Study, Marketing Authorisation Expands Multiple Myeloma Indication. ...
Posted by Michael Wonder on 19 Jul 2022
Enhertu approved in the EU for patients with HER2 positive metastatic breast cancer treated with one or more prior anti-HER2 based regimens
19 July 2022 - Based on groundbreaking DESTINY-Breast03 results in which Enhertu demonstrated a 72% reduction in the risk of ...
Posted by Michael Wonder on 18 Jul 2022
Everest Medicines announces European Commission grants approval of Kinpeygo for adults with primary IgA nephropathy to our partner Calliditas Therapeutics
17 July 2022 - Kinpeygo (developed under the name Nefecon) is the first and only EMA approved treatment for IgAN. ...
Posted by Michael Wonder on 10 Jul 2022
Novavax Nuvaxovid COVID-19 vaccine conditionally authorised in the European Union for adolescents aged 12 through 17
5 July 2022 - Nuvaxovid COVID-19 vaccine is the first protein-based option for adolescents aged 12 through 17 in Europe. ...