13 May 2024 - Supplemental new drug application submission based on Phase 3 study of vibegron 75 mg (Gemtesa) demonstrating statistically ...
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 ...
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. ...
29 April 2024 - Bavarian Nordic today announced that it has initiated the rolling submission process with the US FDA ...
30 April 2024 - Company anticipates 10 month review for potential approval in Q1, 2025. ...
29 April 2024 - FDA PDUFA action expected in Q4, 2024. ...
24 April 2024 - 23 August 2024 assigned as Prescription Drug User Fee Act action date for FDA decision. ...
23 April 2024 - Today, the FDA approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications) for paediatric patients 12 ...
21 April 2024 - Xbrane Biopharma announce that the US FDA has issued a complete response letter to the Company’s ...
22 April 2024 - Abeona Therapeutics today announced a regulatory update for prademagene zamikeracel (pz-cel). ...
16 April 2024 - Submission based on results from pivotal Phase III trial showing all primary outcomes met. ...