Blog
RSS FeedPosted by Michael Wonder on 29 Apr 2025
Fixed-duration Calquence-based regimens recommended for approval in the EU by CHMP for first-line chronic lymphocytic leukaemia
29 April 2025 - Recommendation based on AMPLIFY Phase III trial which showed Calquence combinations demonstrated statistically significant and clinically ...
Posted by Michael Wonder on 28 Apr 2025
Lynozyfic (linvoseltamab) approved in the European Union for the treatment of relapsed/refractory multiple myeloma
28 April 2025 - Regeneron Pharmaceuticals today announced that the European Commission has granted conditional marketing approval of Lynozyfic (linvoseltamab) to ...
Posted by Michael Wonder on 28 Apr 2025
Vertex receives CHMP positive opinion for Alyftrek, a new once-daily CFTR modulator for the treatment of cystic fibrosis
28 April 2025 - In head-to-head clinical trials, deutivacaftor/tezacaftor/vanzacaftor was non-inferior on ppFEV1 and superior compared to Kaftrio (ivacaftor/tezacaftor/elexacaftor) at ...
Posted by Michael Wonder on 28 Apr 2025
Jazz Pharmaceuticals receives CHMP positive opinion for zanidatamab for the treatment of advanced HER2 positive biliary tract cancer
25 April 2025 - Jazz Pharmaceuticals today announced that the CHMP of the EMA has adopted a positive opinion recommending the ...
Posted by Michael Wonder on 28 Apr 2025
New treatment against Duchenne muscular dystrophy
25 April 2025 - Duvyzat can be used in a wide patient population from the age of six. ...
Posted by Michael Wonder on 28 Apr 2025
First treatment against severe thyroid eye disease
25 April 2025 - Tepezza significantly improves symptoms for patients with moderate to severe thyroid eye disease ...
Posted by Michael Wonder on 02 Apr 2025
Valneva’s chikungunya vaccine Ixchiq now authorised in EU for adolescents aged 12 and above
1 April 2025 - With this extension, Ixchiq, the first vaccine against the chikungunya virus, is now available for administration ...
Posted by Michael Wonder on 10 Mar 2025
Wainzua (eplontersen) approved in the EU for the treatment of hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy
10 March 2025 - Second major approval for Wainzua, which is marketed in the US as Wainua. ...
Posted by Michael Wonder on 07 Mar 2025
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable or advanced hepatocellular carcinoma
7 March 2025 - Approval based on results of Phase 3 CheckMate-9DW clinical trial demonstrating a statistically significant and clinically ...
Posted by Michael Wonder on 03 Mar 2025
Imfinzi-based perioperative regimen recommended for approval in the EU by CHMP for resectable non-small cell lung cancer
3 March 2025 - Recommendation based on AEGEAN Phase 3 trial results which showed Imfinzi reduced the risk of recurrence, ...
Posted by Michael Wonder on 02 Mar 2025
Highlights from the 24-27 February 2025 CHMP meeting
28 February 2025 - Four new medicines recommended for approval; another 16 medicines recommended for extension of their therapeutic indications. ...
Posted by Michael Wonder on 02 Mar 2025
Krystal Biotech receives positive CHMP opinion for Vyjuvek for the treatment of dystrophic epidermolysis bullosa
28 February 2025 - EC approval decision anticipated in second quarter of 2025. ...
Posted by Michael Wonder on 08 Feb 2025
Bio-Thera Solutions announces regulatory filing acceptance for BAT2506, a proposed biosimilar to Simponi, in the European Union
7 February 2025 - The BAT2506 marketing authorisation application is based on a robust analytical, non-clinical and clinical data package comparing ...
Posted by Michael Wonder on 06 Feb 2025
Bayer files for approval of finerenone in heart failure in the EU
3 February 2025 - Regulatory submission is based on positive data from the Phase 3 FINEARTS-HF study presented at ESC Congress ...
Posted by Michael Wonder on 20 Nov 2017
EMA to relocate to Amsterdam, the Netherlands
20 November 2017 - Agency to begin working immediately with Dutch government to ensure successful move by end of March ...