Blog
RSS FeedPosted by Michael Wonder on 06 Dec 2021
EMA recommends approval for use of RoActemra in adults with severe COVID-19
6 December 2021 - The EMA’s CHMP has recommended extending the indication of RoActemra (tocilizumab) to include the treatment of ...
Posted by Michael Wonder on 30 Nov 2021
European Commission approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for patients with certain types of endometrial carcinoma
29 November 2021 - Approval based on KEYNOTE-775/Study 309 results demonstrating statistically significant improvements in overall survival and progression-free survival ...
Posted by Michael Wonder on 30 Nov 2021
European Commission approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) as first-line treatment for adult patients with advanced renal cell carcinoma
29 November 2021 - Approval Based on Results From CLEAR/KEYNOTE-581 Trial Demonstrating KEYTRUDA Plus LENVIMA Significantly Reduced the Risk of ...
Posted by Michael Wonder on 26 Nov 2021
European Commission approves Byannli (6 monthly paliperidone palmitate) for the maintenance treatment of schizophrenia in adults
23 November 2021 - The approval is based on results from the Route 6 Study, which showed that 92.5 percent ...
Posted by Michael Wonder on 25 Nov 2021
Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11
25 November 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use ...
Posted by Michael Wonder on 25 Nov 2021
Bristol Myers Squibb receives European Commission approval of Zeposia (ozanimod) for use in adults with moderately to severely active ulcerative colitis
23 November 2021 - Zeposia approval is based on the Phase 3 True North trial, which demonstrated clinically meaningful improvements ...
Posted by Michael Wonder on 24 Nov 2021
Trodelvy (sacituzumab govitecan) granted European Commission marketing authorisation for treatment of metastatic triple negative breast cancer in second line
23 November 2021 - Marketing authorisation based on Phase 3 ASCENT study showing Trodelvy significantly improved overall survival versus physician’s choice ...
Posted 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 ...