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RSS FeedPosted by Michael Wonder on 04 Apr 2023
HUTCHMED completes rolling submission of NDA to US FDA for fruquintinib for the treatment of refractory metastatic colorectal cancer
31 March 2023 - NDA supported by data from global Phase 3 FRESCO-2 study in the US, Europe, Japan and Australia ...
Posted by Michael Wonder on 03 Apr 2023
Vertex and CRISPR Therapeutics complete submission of rolling biologics license applications to the US FDA for exa-cel for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia
3 April 2023 - EU and UK filings completed in 2022; submissions validated by EMA and MHRA and the review ...
Posted by Michael Wonder on 27 Mar 2023
Delcath Systems announces FDA acceptance of new drug application resubmission of Hepzato Kit with a PDUFA date of 14 August 2023
27 March 2023 - Delcath Systems announced that the US FDA has accepted Delcath Systems' new drug application resubmission for Hepzato ...
Posted by Michael Wonder on 27 Mar 2023
Iovance Biotherapeutics completes biologics license application submission for lifileucel in advanced melanoma
24 March 2023 - First TIL therapy BLA submission to US FDA. ...
Posted by Michael Wonder on 27 Mar 2023
EMA validates marketing authorisation application for Henlius' Hansizhuang (serplulimab)
23 March 2023 - Hansizhuang (serplulimab) is the first anti-PD-1 mAb for the first-line treatment of small cell lung cancer. ...
Posted by Michael Wonder on 25 Mar 2023
Incyte provides regulatory update on ruxolitinib extended release tablets
23 March 2023 - Incyte today announced that the US FDA has issued a complete response letter for ruxolitinib extended ...
Posted by Michael Wonder on 15 Mar 2023
China National Medical Products Administration accepts regulatory submission for Nucala (mepolizumab) in severe eosinophilic asthma
14 March 2023 - GSK today announced that the China National Medical Products Administration has accepted for review a new drug ...
Posted by Michael Wonder on 10 Mar 2023
Will NZ neurological drug Trofinetide for Rett syndrome get US FDA approval and make history?
10 March 2023 - Kiwi scientists may be about to make New Zealand history, with a breakthrough treatment on the ...
Posted by Michael Wonder on 10 Mar 2023
Astellas and Seagen announce China's National Medical Products Administration accepts biologics license application for enfortumab vedotin in certain patients with locally advanced or metastatic urothelial cancer
10 March 2023 - Clinical data submitted are consistent with global data and support enfortumab vedotin as a platinum-free option ...
Posted by Michael Wonder on 08 Mar 2023
US FDA accepts supplemental new drug application for Jardiance for children 10 years and older with type 2 diabetes
8 March 2023 - The application is based on phase III results from the DINAMO trial showing Jardiance (empagliflozin) tablets significantly ...
Posted by Michael Wonder on 08 Mar 2023
FDA accepts Mesoblast’s resubmission of the biologic license application for remestemcel-L in children with steroid-refractory acute graft versus host disease as a complete response
7 March 2023 - If approved, remestemcel-L will be the first allogeneic “off the shelf” cellular medicine in the US and ...
Posted by Michael Wonder on 08 Mar 2023
FDA accepts Novan’s NDA for berdazimer 10.3% topical gel for the treatment of molluscum contagiosum
7 March 2023 - FDA completes filing review of application with no filing issues identified. ...
Posted by Michael Wonder on 08 Mar 2023
FDA accepts BioMarin's supplemental new drug application to expand use of Voxzogo (vosoritide) for injection to treat children with achondroplasia under the age of 5
7 March 2023 - FDA set PDUFA target action date of 21 October 2023. ...
Posted by Michael Wonder on 07 Mar 2023
Ionis announces FDA acceptance of new drug application for eplontersen for the treatment of hereditary transthyretin-mediated amyloid polyneuropathy
7 March 2023 - FDA assigns PDUFA action date of 22 December 2023. ...
Posted by Michael Wonder on 07 Mar 2023
BioMarin provides update on FDA review of Roctavian (valoctocogene roxaparvovec) gene therapy for adults with severe haemophilia A
7 March 2023 - FDA extends PDUFA target action date to 30 June 2023. ...