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RSS FeedPosted by Michael Wonder on 14 Jul 2023
European Medicines Agency accepts Astellas' marketing authorisation application for zolbetuximab
13 July 2023 - Astellas Pharma today announced the EMA has accepted for regulatory review the company's marketing authorisation application for ...
Posted by Michael Wonder on 13 Jul 2023
Dr. Reddy’s proposed rituximab biosimilar application accepted for review by US FDA, EMA and MHRA
12 July 2023 - Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review. ...
Posted by Michael Wonder on 04 Jul 2023
Moderna submits regulatory application to the EMA for its updated COVID-19 vaccine
3 July 2023 - The filing follows the recommendation from regulators and global public health bodies to develop monovalent XBB.1.5 COVID-19 ...
Posted by Michael Wonder on 28 Jun 2023
Merck, Ridgeback withdraw COVID drug application in EU
27 June 2023 - Merck and partner Ridgeback Biotherapeutics said on Tuesday they had withdrawn their COVID-19 pill application in ...
Posted by Michael Wonder on 28 Jun 2023
Bristol Myers Squibb receives European Commission approval of Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy
26 June 2023 - Approval based on two positive Phase 3 trials, EXPLORER-HCM and VALOR-HCM, demonstrating significant benefit in patients ...
Posted by Michael Wonder on 27 Jun 2023
Janssen submits marketing authorisation application to the EMA seeking approval of single tablet combination therapy of macitentan and tadalafil for treatment of patients with pulmonary arterial hypertension
26 June 2023 - This is the first and only single tablet combination therapy to be submitted for review in Europe ...
Posted by Michael Wonder on 25 Jun 2023
Use of real world evidence in regulatory decision making – EMA publishes review of its studies
23 June 2023 - Real world evidence from studies led by regulators can complement evidence from other sources including clinical trials. ...
Posted by Michael Wonder on 24 Jun 2023
Leo Pharma receives positive CHMP opinion for new Adtralza (tralokinumab) injection device
23 June 2023 - CHMP recommends approval of the Adtralza pre-filled pen. ...
Posted by Michael Wonder on 20 Jun 2023
Legacy Healthcare announces EMA validation of marketing authorisation application for coacillium for the treatment of moderate and severe alopecia areata in children and adolescents
19 June 2023 - Legacy Healthcare today announced that its marketing authorisation application to the EMA's CHMP for Coacillium for the ...
Posted by Michael Wonder on 16 Jun 2023
Takeda and HUTCHMED announce marketing authorisation application of fruquintinib for previously treated metastatic colorectal cancer validated by the European Medicines Agency
15 June 2023 - Application Includes Data from Phase 3 FRESCO-2 and FRESCO Clinical Trials, which Demonstrated Superiority of Fruquintinib Plus ...
Posted by Michael Wonder on 26 May 2023
Janssen seeks European Commission approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the earlier treatment of patients with relapsed and refractory multiple myeloma
25 May 2023 - Application to the EMA is supported by data from the Phase 3 CARTITUDE-4 study, which evaluated the ...
Posted by Michael Wonder on 25 May 2023
Sandoz marketing authorisation applications for proposed biosimilar denosumab accepted by EMA
25 May 2023 - Submissions supported by comprehensive analytical and clinical data package including a Phase I PK/PD similarity study and ...
Posted by Michael Wonder on 23 May 2023
Pierre Fabre announces start of EU marketing authorization application procedure for vibegron in overactive bladder
22 May 2023 - Following the exclusive licensing agreement with Urovant Sciences, Pierre Fabre announced today the start of the ...
Posted by Michael Wonder on 20 May 2023
EMA validates marketing authorisation application for efanesoctocog alfa for treatment of haemophilia A
19 May 2023 - Sobi today announced that the EMA has accepted and validated a marketing authorisation application for efanesoctocog alfa, ...
Posted by Michael Wonder on 11 May 2023
Servier receives European Commission approval of Tibsovo (ivosidenib tablets) in IDH1 mutated acute myeloid leukaemia and IDH1 mutated cholangiocarcinoma
10 May 2023 - Marketing Authorization granted for Tibsovo as the first and only approved IDH1 targeted therapy in Europe. ...