3 April 2024 - Submission of complete response letter response triggers up to six month review period by the FDA. ...
4 April 2024 - Application in moderate to severe hidradenitis suppurativa based on results from two Phase 3 studies where ...
2 April 2024 - Zymeworks is pleased to announce, along with our partners Jazz Pharmaceuticals, completion of the rolling submission of ...
2 April 2024 - Application based on results from the TROPION-Breast01 Phase 3 trial. ...
1 April 2024 - Eisai and Biogen announced today that Eisai submitted to the US FDA a supplemental biologics license ...
1 April 2024 - Target action date set for 19 November 2024. ...
26 March 2024 - PDUFA action date set for 26 September 2024. ...
20 March 2024 - Idorsia plans to make Tryvio available to the millions of patients in the US who are not ...
18 March 2024 - FDA assigns Prescription Drug User Fee Act target action date of 13 August 2024 ...
11 March 2024 - Submission is supported by data from the Phase 3 QUASAR program, which showed a significantly greater percentage ...
11 March 2024 - Submission is based on 2 year confirmatory results from the Phase 3 PROTECT study in which Filspari ...
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. ...