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RSS FeedPosted by Michael Wonder on 27 Jan 2023
Dupixent (dupilumab) recommended for expanded EU approval by the CHMP to treat children as young as six months old with severe atopic dermatitis
27 January 2023 - Recommendation based on a Phase 3 trial in children 6 months to 5 years old showing Dupixent ...
Posted by Michael Wonder on 26 Jan 2023
Enhertu approved in the EU as the first HER2 directed therapy for patients with HER2 low metastatic breast cancer
26 January 2023 - Approval based on DESTINY-Breast04 results where AstraZeneca and Daiichi Sankyo’s Enhertu reduced the risk of disease ...
Posted by Michael Wonder on 14 Jan 2023
Roche announces the European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above
12 January 2023 - Xofluza is now approved in the EU for the treatment of uncomplicated influenza and for post-exposure prophylaxis ...
Posted by Michael Wonder on 13 Jan 2023
Tezspire approved for self-administration in the EU in a new pre-filled pen
13 January 2023 - New administration option for first and only severe asthma biologic approved in the EU with no ...
Posted by Michael Wonder on 21 Dec 2022
European Commission approves Eladynos (abaloparatide) for the treatment of osteoporosis in post-menopausal women at increased risk of fracture
19 December 2022 - Radius Health announced that the European Commission has granted marketing authorisation for abaloparatide under the trade name ...
Posted by Michael Wonder on 21 Dec 2022
Lynparza in combination with abiraterone approved in the EU as first-line treatment for patients with metastatic castration-resistant prostate cancer
21 December 2022 - First approved PARP inhibitor to demonstrate clinically meaningful benefits in combination with a new hormonal agent. ...
Posted by Michael Wonder on 21 Dec 2022
Imfinzi plus chemotherapy approved in the EU as first immunotherapy regimen for patients with advanced biliary tract cancer
21 December 2022 - Approval based on TOPAZ-1 updated survival results showing Imfinzi combination reduced risk of death by 24% ...
Posted by Michael Wonder on 20 Dec 2022
Atara Biotherapeutics’ Ebvallo (tabelecleucel) receives European Commission approval as first ever therapy for adults and children with EBV+ PTLD
19 December 2022 - Pierre Fabre to lead commercialisation and distribution activities in Europe. ...
Posted by Michael Wonder on 19 Dec 2022
Forxiga recommended for approval in the EU by CHMP for symptomatic chronic heart failure
19 December 2022 - f approved, Forxiga will be the first heart failure therapy indicated across the full ejection fraction ...
Posted by Michael Wonder on 19 Dec 2022
Enhertu recommended for approval in the EU by CHMP for patients with HER2 low metastatic breast cancer
19 December 2022 - AstraZeneca and Daiichi Sankyo’s Enhertu is the first HER2 directed therapy to demonstrate a significant survival ...
Posted by Michael Wonder on 19 Dec 2022
Enhertu approved in the EU for patients with previously treated HER2 positive advanced gastric cancer
19 December 2022 - Based on DESTINY-Gastric02 and DESTINY-Gastric01 where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated clinically meaningful efficacy. ...
Posted by Michael Wonder on 19 Dec 2022
Fintepla (fenfluramine) oral solution recommended for approval in the EU for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome
19 December 2022 - Recommendation based on Phase 3 trial data demonstrating safety and efficacy in the most difficult to treat ...
Posted by Michael Wonder on 18 Dec 2022
Amicus Therapeutics receives positive CHMP opinion for Pombiliti (cipaglucosidase alfa) for late-onset Pompe disease
16 December 2022 - CHMP adopts positive opinion based upon complete review of all pre-clinical, clinical studies and CMC data. ...
Posted by Michael Wonder on 18 Dec 2022
Finerenone receives positive CHMP opinion for EU label extension for broad range of patients with chronic kidney disease and type 2 diabetes
16 December 2022 - CHMP opinion is based on the results from the Phase 3 FIGARO-DKD cardiovascular outcomes trial in patients ...
Posted by Michael Wonder on 18 Dec 2022
CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A
16 December 2022 - The positive CHMP opinion is based on the results of the HAVEN 6 trial, which demonstrated effective ...