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RSS FeedPosted by Michael Wonder on 18 Nov 2023
Polaris Group initiates rolling submission of biologic license application for ADI-PEG 20 with US FDA to treat malignant pleural mesothelioma
16 November 2023 - Polaris Group today announced that the Company has initiated the rolling submission of its biologic license ...
Posted by Michael Wonder on 16 Nov 2023
Ascendis Pharma resubmits NDA for TransCon PTH to the US FDA
15 November 2023 - Ascendis Pharma today announced that it has resubmitted its new drug application for TransCon PTH (palopegteriparatide) for ...
Posted by Michael Wonder on 09 Nov 2023
US FDA accepts for priority review Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) for relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma
9 November 2023 - Application based on results from TRANSCEND CLL 004, the first pivotal multi-centre trial to show clinical benefit ...
Posted by Michael Wonder on 08 Nov 2023
Samsung Bioepis & Organon announce FDA acceptance of supplemental biologics license application for interchangeability designation for Hadlima (adalimumab-bwwd), a biosimilar to Humira
7 November 2023 - Supplemental biologics license application based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: ...
Posted by Michael Wonder on 08 Nov 2023
Janssen submits Phase 3 study data to the European Medicines Agency and US Food and Drug Administration for Sirturo (bedaquiline)
7 November 2023 - STREAM Stage 2 study data submitted as part of type II variation to the EMA and supplemental ...
Posted by Michael Wonder on 02 Nov 2023
Supernus announces SPN-830 apomorphine infusion device NDA accepted for review by FDA
2 November 2023 - PDUFA target action date of 5 April 2024. ...
Posted by Michael Wonder on 31 Oct 2023
Day One announces FDA acceptance of NDA and priority review for tovorafenib in relapsed or progressive paediatric low grade glioma
30 October 2024 - Priority review granted with PDUFA target action date of 30 April 2024. ...
Posted by Michael Wonder on 26 Oct 2023
FDA accepts ImmunityBio’s BLA resubmission as complete and sets new PDUFA date
26 October 2023 - A new PDUFA date of 23 April 2024 has been communicated by the Agency. ...
Posted by Michael Wonder on 25 Oct 2023
Akebia receives FDA acceptance of resubmission to NDA of vadadustat for the treatment of anaemia due to chronic kidney disease
25 October 2023 - 27 March 2024 set as user fee goal date. ...
Posted by Michael Wonder on 24 Oct 2023
Milestone Pharmaceuticals announces submission of new drug application to the US FDA for etripamil
24 October 2023 - Comprehensive data package includes positive results from pivotal Phase 3 RAPID trial which company believes demonstrates new ...
Posted by Michael Wonder on 24 Oct 2023
ImmunityBio announces biological license application resubmission for N-803 in BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ
23 October 2023 - Following the type A meeting with the FDA, ImmunityBio has completed the BLA resubmission addressing the issues ...
Posted by Michael Wonder on 24 Oct 2023
US Food and Drug Administration accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent
24 October 2023 - Potential to be the first and only self-administered flu vaccine. ...
Posted by Michael Wonder on 20 Oct 2023
Regeneron and Sanofi provide update on Dupixent (dupilumab) sBLA for chronic spontaneous urticaria
20 October 2023 - Regeneron Pharmaceuticals and Sanofi today announced that the US FDA has issued a complete response letter for ...
Posted by Michael Wonder on 19 Oct 2023
BrainStorm Cell Therapeutics to meet with US FDA to discuss development plan for NurOwn as a treatment of ALS
18 October 2023 - Biologics license application to be withdrawn without prejudice. ...
Posted by Michael Wonder on 18 Oct 2023
Mirum Pharmaceuticals announces new PDUFA date for Livmarli for the treatment of cholestatic pruritus in progressive familial intrahepatic cholestasis
17 October 2023 - Mirum Pharmaceuticals today announced that the US FDA has extended the review of the supplemental new drug ...