11 March 2024 - Viatris has been informed that Mapi Pharma has received a complete response letter regarding the new drug ...
10 March 2024 - The BLA for CT-P39 was based on totality of evidence including results from Phase III data ...
6 March 2024 - Vanda Pharmaceuticals today announced that on 4 March 2024, it received a complete response letter from ...
5 March 2024 - PDUFA set to 21 October 2024. ...
4 March 2024 - The new PDUFA action date set by the FDA is 21 September 2024. ...
4 March 2024 - SpringWorks Therapeutics announced today that the Company has initiated a rolling submission of a new drug application ...
29 February 2024 - FDA has assigned a PDUFA target action date of 15 October 2024. ...
28 February 2024 - PDUFA target action date of 28 August 2024. ...
27 February 2024 - Priority review acceptance based on positive results of AGAVE-201 study. ...
27 February 2024 - Theratechnologies today announced that the US FDA has issued a refusal to file letter regarding the Company’s ...
27 February 2024 - Application based on results from global Phase 3 RATIONALE-305 trial demonstrating Tevimbra plus chemotherapy significantly improved overall ...
27 February 2024 - Minerva Neurosciences announced today that the US FDA has issued a complete response letter to the ...
26 February 2024 - FDA grants priority review with target action date of 28 June 2024. ...
23 February 2024 - Priority review granted based on positive results from two Phase 3 trials; if approved, Dupixent would be ...
21 February 2024 - Prescription Drug User Fee Act date is 21 June 2024. ...