Blog
RSS FeedPosted 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18 October 2023 - Biologics license application to be withdrawn without prejudice.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 ...
Posted by Michael Wonder on 16 Oct 2023
Tagrisso plus chemotherapy granted priority review in the US for patients with EGFR mutated advanced lung cancer
16 October 2023 - Decision based on FLAURA2 Phase 3 trial results which extended median progression-free survival by nearly 9 ...
Posted by Michael Wonder on 14 Oct 2023
Catalyst Pharmaceuticals announces FDA acceptance of the supplemental new drug application for Firdapse
13 October 2023 - US FDA assigned target action date of 4 June 2024. ...
Posted by Michael Wonder on 12 Oct 2023
Alvotech provides update on status of US biologics license application for AVT04
12 October 2023 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s biologics ...
Posted by Michael Wonder on 09 Oct 2023
Alnylam announces receipt of complete response letter from US FDA for supplemental new drug application for patisiran for the treatment of the cardiomyopathy of ATTR amyloidosis
9 October 2023 - FDA cites insufficient evidence of clinical meaningfulness. ...
Posted by Michael Wonder on 08 Oct 2023
Sun Pharma announces US FDA filing acceptance of new drug application for deuruxolitinib
6 October 2023 - Deuruxolitinib is being evaluated for treatment of moderate to severe alopecia areata. ...
Posted by Michael Wonder on 08 Oct 2023
FDA approves Novartis Cosentyx as first intravenous formulation interleukin-17A antagonist for rheumatic diseases
6 October 2023 - First new intravenous treatment option in six years for adults with psoriatic arthritis, ankylosing spondylitis and non-radiographic ...