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RSS FeedPosted by Michael Wonder on 20 Aug 2024
European Commission grants second indication approval for Tepkinly (epcoritamab) for the treatment of adults with relapsed/refractory follicular lymphoma
20 August 2024 - AbbVie today announced that the European Commission has granted conditional marketing authorisation for Tepkinly (epcoritamab) as a ...
Posted by Michael Wonder on 14 Aug 2024
Lynparza and Imfinzi combination approved in the EU for patients with mismatch repair proficient advanced or recurrent endometrial cancer
14 August 2024 - First immunotherapy and PARP inhibitor combination approved in endometrial cancer. ...
Posted by Michael Wonder on 08 Aug 2024
Takeda receives European Commission approval for Adzynma (recombinant ADAMTS13) as the first and only recombinant ADAMTS13 replacement therapy for congenital thrombotic thrombocytopenic purpura
7 August 2024 - Approval based on totality of evidence, including results from the first randomised, controlled, open-label, cross-over Phase ...
Posted by Michael Wonder on 05 Aug 2024
UCB announces European Commission approval for 320 mg device presentations of Bimzelx (bimekizumab)
5 August 2024 - Patients requiring a 320 mg dose of bimekizumab will now have an alternative single injection option of ...
Posted by Michael Wonder on 01 Aug 2024
CHMP recommends Rybrevant (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced EGFR mutated non-small cell lung cancer after failure of prior therapy
31 July 2024 - CHMP recommends Rybrevant (amivantamab) in combination with chemotherapy for the treatment of adult patients with advanced ...
Posted by Michael Wonder on 01 Aug 2024
Prestige Biopharma's Herceptin biosimilar Tuznue receives positive CHMP opinion from the EMA
31 July 2024 - Following approval by the European Commission, Prestige Biopharma's Herceptin biosimilar Tuznue would become the first biosimilar from ...
Posted by Michael Wonder on 31 Jul 2024
EMA approves Bio-Thera Solutions' BAT1706 (Avzivi, bevacizumab), a biosimilar referencing Avastin
30 July 2024 - Bio-Thera Solutions today announced that the EMA has approved BAT1706 (bevacizumab), a biosimilar referencing Avastin. ...
Posted by Michael Wonder on 30 Jul 2024
European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion
30 July 2024 - Approval is based on data from two Phase 3 studies in branch and central retinal vein occlusion ...
Posted by Michael Wonder on 29 Jul 2024
CStone announces European Commission approval of Sugemalimab (Cejemly) as first-line treatment for non-small cell lung cancer
26 July 2024 - The European Commission approval is based on the results of GEMSTONE-302 Phase 3 trial, which demonstrated that ...
Posted by Michael Wonder on 27 Jul 2024
Leo Pharma receives positive CHMP opinion of Anzupgo (delgocitinib cream) for the treatment of adults with moderate to severe chronic hand eczema
26 July 2024 - The positive opinion is based on results from the DELTA phase 3 program, which includes the randomised, ...
Posted by Michael Wonder on 27 Jul 2024
Ipsen receives CHMP positive opinions for Iqirvo (elafibranor) in primary biliary cholangitis and Kayfanda (odevixibat) in Alagille syndrome, two rare cholestatic liver diseases
26 July 2024 - Ipsen announced today two positive opinions by the EMA's CHMP for two different rare cholestatic liver disease ...
Posted by Michael Wonder on 27 Jul 2024
Astellas receives positive CHMP opinion for zolbetuximab in combination with chemotherapy for treatment of advanced gastric and gastro-oesophageal junction cancer
26 July 2024 - If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2 targeted therapy approved ...
Posted by Michael Wonder on 27 Jul 2024
Astellas receives positive CHMP opinion for Padcev (enfortumab vedotin) in combination with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
26 July 2024 - Positive opinion is based on Phase 3 EV-302 clinical trial results which showed enfortumab vedotin in combination ...
Posted by Michael Wonder on 26 Jul 2024
AbbVie announces European Commission approval of Skyrizi (risankizumab) for the treatment of adults with moderately to severely active ulcerative colitis
26 July 2024 - The approval is supported by data from two pivotal Phase 3 trials: the INSPIRE induction trial and ...
Posted by Michael Wonder on 26 Jul 2024
European Commission approves Pfizer’s Durveqtix (fidanacogene elaparvovec), a one-time gene therapy for adults with haemophilia B
25 July 2024 - A one-time dose of Durveqtix has reduced bleeds post-treatment compared to standard of care with a median ...