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. ...
8 April 2024 - Purdue Pharma announced today that FDA has accepted for filing the company’s new drug application for the ...
9 April 2024 - Lundbeck and Otsuka have submitted a supplemental new drug application for US FDA review of brexpiprazole ...
8 April 2024 - Second FDA acceptance for an NDA filing by Shorla Oncology announced in 2024. ...
8 April 2024 - Supernus Pharmaceuticals today announced a regulatory update for SPN-830. ...
8 April 2024 - If approved, elamipretide would become the first approved therapy for Barth syndrome. ...
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 ...