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RSS FeedPosted 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 ...
Posted by Michael Wonder on 10 Jul 2024
Mirum Pharmaceuticals’ Livmarli approved in the European Union for patients with progressive familial intrahepatic cholestasis
8 July 2024 - Mirum Pharmaceuticals today announced that the European Commission has granted marketing authorization for Livmarli (maralixibat) oral solution ...
Posted by Michael Wonder on 05 Jul 2024
Tagrisso with the addition of chemotherapy approved in the EU as new first-line treatment for patients with EGFR-mutated advanced lung cancer
5 July 2024 - Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...
Posted by Michael Wonder on 03 Jul 2024
Johnson & Johnson receives approval from US FDA and European Commission for Sirturo (bedaquiline)
2 July 2024 - Johnson & Johnson announced today that the US FDA has issued traditional approval for Sirturo (bedaquiline) ...
Posted by Michael Wonder on 03 Jul 2024
Dupixent (dupilumab) approved in the European Union as the first ever targeted therapy for patients with COPD
3 July 2024 - First in world approval of Dupixent for adults with uncontrolled COPD with raised blood eosinophils based on ...
Posted by Michael Wonder on 02 Jul 2024
Idorsia’s Jeraygo (aprocitentan) approved in Europe as first and only ERA for the treatment of resistant hypertension
1 July 2024 - Jeraygo is a new oral antihypertensive therapy – the first in almost 40 years – that is ...
Posted by Michael Wonder on 02 Jul 2024
Pierre Fabre Laboratories announce granting of European marketing authorisation for Obgemsa (vibegron) in overactive bladder
28 June 2024 - The European Commission has authorised the marketing of Obgemsa (vibegron) by Pierre Fabre Laboratories for the symptomatic ...
Posted by Michael Wonder on 02 Jul 2024
Valneva receives marketing authorisation in Europe for the world’s first chikungunya vaccine Ixchiq
1 July 2024 - 2024 – Valneva today announced that the European Commission has granted marketing authorisation in Europe for Valneva’s ...
Posted by Michael Wonder on 01 Jul 2024
CHMP recommends EU approval of Roche’s PiaSky for people with PNH, a rare, life-threatening blood condition
28 June 2024 - The recommendation is based on the COMMODORE 2 study results, where SC PiaSky given every month demonstrated ...