16 May 2024 - Axogen is pleased to announce that it has initiated the rolling submission process with the US FDA ...
14 May 2024 - Dynavax Technologies today provided a regulatory update for the Company's supplemental biologics license application to include ...
14 May 2024 - PDUFA goal date extended by three months for further review of submission to 14 August 2024. ...
15 May 2024 - BioArctic's partner Eisai announced today that they have initiated the rolling submission of a biologics license application ...
14 May 2024 - PDUFA target action date of 13 November 2024. ...
13 May 2024 - Supplemental new drug application submission based on Phase 3 study of vibegron 75 mg (Gemtesa) demonstrating statistically ...
13 May 2024 - Outlook Therapeutics today announced the submission of its marketing authorisation application to the Medicines and Healthcare ...
13 May 2024 - If approved, Dupixent would be the first treatment in the US indicated for adolescents aged 12-17 years ...
10 May 2024 - US FDA has informed Moderna that due to administrative constraints, the agency will not complete its review ...
6 May 2024 - If approved, zenocutuzumab will be the first targeted therapy for NRG1 positive cancer. ...
6 May 2024 - Application based on results from CheckMate-67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab ...
6 May 2024 - Application based on results from the CheckMate-8HW study, in which Opdivo plus Yervoy demonstrated statistically significant ...
1 May 2024 - Submission included data from the Phase 3 QUASAR program in ulcerative colitis and the Phase 3 GALAXI ...
30 April 2024 - Neurocrine Biosciences today announced the US FDA has approved Ingrezza Sprinkle (valbenazine) capsules, a new oral ...
29 April 2024 - Potential approval early Q4, 2024. ...