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RSS FeedPosted 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 ...
Posted by Michael Wonder on 17 Jun 2024
Bavarian Nordic completes BLA submission to US FDA for its Chikungunya vaccine candidate
17 June 2024 - First regulatory submission completed for CHIKV VLP seeking approval of the vaccine candidate for immunisation against chikungunya ...
Posted by Michael Wonder on 15 Jun 2024
Novavax submits application to US FDA for updated protein based 2024-2025 formula COVID-19 vaccine
14 June 2024 - Novavax's updated JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3. ...
Posted by Michael Wonder on 13 Jun 2024
Receipt of complete response letter from US FDA for ND0612
11 June 2024 - Mitsubishi Tanabe Pharma today announced that the US FDA has issued a complete response letter for ...
Posted by Michael Wonder on 10 Jun 2024
Tagrisso granted priority review in the US for patients with unresectable, stage III EGFR mutated lung cancer
10 June 2024 - Decision based on LAURA Phase 3 trial results which extended median progression-free survival by more than ...
Posted by Michael Wonder on 10 Jun 2024
FDA accepts filing of Leqembi (lecanemab-irmb) sBLA for IV maintenance dosing for the treatment of early Alzheimer's Disease
8 June 2024 - Eisai announced today that that the US FDA has accepted Eisai's supplemental biologics license application for ...
Posted by Michael Wonder on 08 Jun 2024
Moderna files FDA application for the JN.1 targeting COVID-19 vaccine
7 June 2024 - Manufacturing is underway and doses of Moderna's Spikevax 2024-2025 formula will be ready to ship as ...
Posted by Michael Wonder on 06 Jun 2024
FDA accepts for review treosulfan NDA resubmission
6 June 2024 - Today, Medexus Pharmaceuticals was informed by medac, licensor of Medexus's commercialisation rights to treosulfan, that the ...
Posted by Michael Wonder on 05 Jun 2024
Johnson & Johnson submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Prezcobix
4 June 2024 - Johnson & Johnson today announced the submission of a supplemental new drug application to the US FDA ...