10 April 2024 - AdrenoMed today announced that the US FDA has granted fast track designation to its lead product candidate ...
10 April 2024 - Public comment period now open until 7 May 2024; requests to make oral comment during public ...
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 ...
9 April 2024 - Syros Pharmaceuticals today announced that the US FDA has granted fast track designation to tamibarotene in ...
9 April 2024 - Input period now open until 13 May 2024. ...
8 April 2024 - Dovato is now the first and only oral, two drug, single-tablet regimen available for people aged 12 ...
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. ...
8 April 2024 - Phanes Therapeutics announced today that the US FDA has granted fast track designation to PT217 for the ...
3 April 2024 - Submission of complete response letter response triggers up to six month review period by the FDA. ...
7 April 2024 - In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did ...
5 April 2024 - Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with Carvykti ...
7 April 2024 - Dizal today announced that the US FDA has granted breakthrough therapy designation to its sunvozertinib as ...