19 February 2024 - Starpharma today announces that it has completed the formal dispute resolution process with the US FDA in ...
19 February 2024 - Application based on results from the TROPION-Lung01 Phase 3 trial. ...
15 February 2024 - Priority review designation is based on results from the Phase 3 EV-302 trial, which found enfortumab vedotin ...
16 February 2024 - Priority review granted, with a review goal date of 21 June 2024. ...
13 February 2024 - FDA acceptance of the completed resubmission package and issuance of a Prescription Drug User Fee Act ...
14 February 2024 - sNDA is supported by positive data from the Phase 3 ADORING 1 and ADORING 2 pivotal trials ...
13 February 2024 - New Prescription Drug User Fee Act date of 30 June 2024. ...
14 February 2024 - Nemolizumab was granted US FDA priority review for prurigo nodularis. ...
14 February 2024 - The US FDA assigned a target action date of 15 June 2024. ...
13 February 2024 - Celltrion said it has completed its application for marketing authorisation to the EMA for CT-P47, a ...
12 February 2024 - FDA has granted priority review with a target PDUFA date of 14 August 2024. ...
12 February 2024 - The US FDA has accepted the resubmission of Xspray Pharma’s new drug application for Dasynoc, following ...
12 February 2024 - 12 weeks of treatment with Eohilia may address significant unmet needs of patients 11 years of age ...
9 February 2024 - PDUFA date set for 10 August 2024. ...
9 February 2024 - PDUFA date is 11 August 2024. ...