Blog
RSS FeedPosted by Michael Wonder on 18 Nov 2023
Almirall receives European Commission Approval of Ebglyss (lebrikizumab) for moderate to severe atopic dermatitis
17 November 2023 - Following the European Commission approval, Germany is the first country where lebrikizumab will be available for prescription. ...
Posted by Michael Wonder on 15 Nov 2023
Roche’s subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types
14 November 2023 - If approved, Tecentriq subcutaneous would be the first injectable PD-(L)1 cancer immunotherapy in the EU, cutting treatment ...
Posted by Michael Wonder on 13 Nov 2023
MediWound receives positive CHMP opinion recommending approval for NexoBrid to treat paediatric patients
13 November 2023 - The label expansion will solidify NexoBrid’s position in the EU as a safe and effective non-surgical treatment ...
Posted by Michael Wonder on 13 Nov 2023
GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia
13 November 2023 - If approved, momelotinib will become the first and only treatment in the EU specifically indicated for myelofibrosis ...
Posted by Michael Wonder on 11 Nov 2023
Bayer’s aflibercept 8 mg recommended for approval in EU
10 November 2023 - Recommendation by the CHMP based on positive results from PULSAR clinical trial in neovascular (wet) age-related macular ...
Posted by Michael Wonder on 11 Nov 2023
Highlights from the 6-9 November 2023 CHMP meeting
10 November 2023 - The EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its November 2023 meeting. ...
Posted by Michael Wonder on 10 Nov 2023
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) plus gemcitabine and cisplatin as first-line treatment for locally advanced unresectable or metastatic biliary tract cancer
10 November 2023 - Opinion granted based on positive overall survival results from the Phase 3 KEYNOTE‑966 trial. ...
Posted by Michael Wonder on 10 Nov 2023
Blueprint Medicines' Ayvakyt (avapritinib) receives positive CHMP opinion as the first and only therapy for indolent systemic mastocytosis
10 November 2023 - Opinion based on the positive PIONEER trial, in which once daily Ayvakyt achieved significant improvements across ...
Posted by Michael Wonder on 10 Nov 2023
Mirati Therapeutics receives positive opinion from CHMP for Krazati (adagrasib) as a targeted treatment option for patients with advanced non-small cell lung cancer with a KRAS G12C mutation following a re-examination procedure
10 November 2023 - Mirati Therapeutics today announced that following a re-examination procedure, the Company has received a positive opinion ...
Posted by Michael Wonder on 10 Nov 2023
UCB receives CHMP positive opinion for rozanolixizumab for treatment of adults with generalised myasthenia gravis in Europe
10 November 2023 - The CHMP positive opinion is based on the pivotal Phase 3 MycarinG study in generalised myasthenia gravis ...
Posted by Michael Wonder on 10 Nov 2023
STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara
10 November 2023 - CHMP positive opinion in the European Economic Area for first biosimilar to Stelara, a biologic therapy within ...
Posted by Michael Wonder on 09 Nov 2023
Getting ready for EMA’s website relaunch on 5 December 2023
9 November 2023 - The EMA is relaunching its corporate website on 5 December 2023. ...
Posted by Michael Wonder on 09 Nov 2023
Vanflyta approved in the EU as the first FLT3 inhibitor specifically for patients with newly diagnosed FLT3-ITD positive AML
9 November 2023 - Approval based on QuANTUM-First results demonstrating Vanflyta added to chemotherapy improved overall survival. ...
Posted by Michael Wonder on 08 Nov 2023
First electronic product information published for selected human medicines
8 November 2023 - The Heads of Medicines Agencies (HMA), the European Commission and EMA have published for the first time ...
Posted by Michael Wonder on 08 Nov 2023
Janssen submits Phase 3 study data to the European Medicines Agency and US Food and Drug Administration for Sirturo (bedaquiline)
7 November 2023 - STREAM Stage 2 study data submitted as part of type II variation to the EMA and supplemental ...