26 June 2024 - As part of the reauthorisation of the Prescription Drug User Fee Act (PDUFA VII), FDA committed ...
28 June 2024 - Soleno Therapeutics today announced the submission of a n ew drug application to the US FDA for ...
28 June 2024 - Mirum Pharmaceuticals today announced the submission of a new drug application for chenodiol for the treatment of ...
26 June 2024 - Olezarsen PDUFA date set for 19 December 2024 for treatment of familial chylomicronemia syndrome. ...
25 June 2024 - The FDA target date (PDUFA date) for completion of the review is 8 February 2025. ...
21 June 2024 - Lexicon seeks approval for sotagliflozin as an adjunct to insulin therapy for glycemic control in people with ...
20 June 2024 - Priority review granted with a PDUFA goal date set for 17 December 2024. ...
20 June 2024 - Submission is supported by 48 week results from the Phase 3 GALAXI and GRAVITI programs. ...
18 June 2024 - KalVista Pharmaceuticals today announced the submission of a new drug application for US FDA review of ...
17 June 2024 - Application based on Phase 3 PALOMA-3 results showing five-fold reduction in infusion-related reactions with five minute administration ...
17 June 2024 - First regulatory submission completed for CHIKV VLP seeking approval of the vaccine candidate for immunisation against chikungunya ...
14 June 2024 - Novavax's updated JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3. ...
11 June 2024 - Mitsubishi Tanabe Pharma today announced that the US FDA has issued a complete response letter for ...
10 June 2024 - Decision based on LAURA Phase 3 trial results which extended median progression-free survival by more than ...
8 June 2024 - Eisai announced today that that the US FDA has accepted Eisai's supplemental biologics license application for ...