Blog
RSS FeedPosted by Michael Wonder on 03 Jul 2024
Sobi initiates rolling biologics license application to FDA for SEL-212 for the potential treatment of chronic refractory gout
2 July 2024 - Sobi today announced the initiation of a rolling biologics license application to the US FDA for SEL-212. ...
Posted by Michael Wonder on 02 Jul 2024
FDA approves treatment for adults with Alzheimer’s disease
2 July 2024 - The US FDA has approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease. ...
Posted by Michael Wonder on 02 Jul 2024
Vertex announces FDA acceptance of new drug application for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis
2 July 2024 - Vanza triple granted priority review with a PDUFA target action date of 2 January 2025. ...
Posted by Michael Wonder on 02 Jul 2024
SpringWorks Therapeutics completes submission of new drug application to the FDA for mirdametinib for the treatment of children and adults with NF1-PN
1 July 2024 - SpringWorks Therapeutics announced today that the Company has completed the submission of a new drug application to ...
Posted by Michael Wonder on 01 Jul 2024
Neurocrine Biosciences announces US FDA accepts new drug applications and grants priority review for crinecerfont for paediatric and adult patients with CAH
1 July 2024 - PDUFA target action dates in late December 2024. ...
Posted by Michael Wonder on 01 Jul 2024
Real world evidence submissions to the Center for Biologics Evaluation and Research
26 June 2024 - As part of the reauthorisation of the Prescription Drug User Fee Act (PDUFA VII), FDA committed ...
Posted by Michael Wonder on 29 Jun 2024
Soleno Therapeutics announces submission of new drug application to the US FDA for diazoxide choline extended-release tablets for the treatment of Prader-Willi syndrome
28 June 2024 - Soleno Therapeutics today announced the submission of a n ew drug application to the US FDA for ...
Posted by Michael Wonder on 29 Jun 2024
Mirum submits new drug application to FDA for chenodiol for the treatment of CTX
28 June 2024 - Mirum Pharmaceuticals today announced the submission of a new drug application for chenodiol for the treatment of ...
Posted by Michael Wonder on 27 Jun 2024
Ionis announces olezarsen FCS new drug application accepted for priority review
26 June 2024 - Olezarsen PDUFA date set for 19 December 2024 for treatment of familial chylomicronemia syndrome. ...
Posted by Michael Wonder on 26 Jun 2024
Otsuka and Lundbeck announce FDA acceptance of sNDA filing for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder
25 June 2024 - The FDA target date (PDUFA date) for completion of the review is 8 February 2025. ...
Posted by Michael Wonder on 23 Jun 2024
Lexicon Pharmaceuticals resubmits sotagliflozin NDA for type 1 diabetes
21 June 2024 - Lexicon seeks approval for sotagliflozin as an adjunct to insulin therapy for glycemic control in people with ...
Posted by Michael Wonder on 23 Jun 2024
Neurotech Pharmaceuticals receives priority review of biologics license application for NT-501 (revakinagene taroretcel) as a treatment for macular telangiectasia type 2
20 June 2024 - Priority review granted with a PDUFA goal date set for 17 December 2024. ...
Posted by Michael Wonder on 21 Jun 2024
Johnson & Johnson submits application to US FDA seeking approval of Tremfya (guselkumab) for the treatment of moderately to severely active Crohn's disease
20 June 2024 - Submission is supported by 48 week results from the Phase 3 GALAXI and GRAVITI programs. ...
Posted by Michael Wonder on 20 Jun 2024
KalVista submits new drug application to FDA for sebetralstat as first oral on-demand treatment for hereditary angioedema
18 June 2024 - KalVista Pharmaceuticals today announced the submission of a new drug application for US FDA review of ...
Posted by Michael Wonder on 18 Jun 2024
Subcutaneous amivantamab biologics license application submitted to US FDA for patients with EGFR mutated non-small-cell lung cancer
17 June 2024 - Application based on Phase 3 PALOMA-3 results showing five-fold reduction in infusion-related reactions with five minute administration ...