26 March 2024 - PDUFA action date set for 26 September 2024. ...
25 March 2024 - TNX-2900 is a proprietary magnesium-potentiated formulation of intranasal oxytocin, a naturally occurring hormone that reduces appetite and ...
25 March 2024 - Argenica Therapeutics is pleased to announce the US FDA has granted its neuroprotective drug ARG-007 rare ...
21 March 2024 - Lisata Therapeutics today announced that the US FDA has granted rare paediatric disease designation to LSTA1, the ...
19 March 2024 - Deverra Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to its lead ...
13 March 2024 - PepGen today announced that the US FDA granted both orphan drug and rare paediatric disease designations for ...
28 February 2024 - PDUFA target action date of 28 August 2024. ...
27 February 2024 - Priority review acceptance based on positive results of AGAVE-201 study. ...
26 February 2024 - FDA grants priority review with target action date of 28 June 2024. ...
23 February 2024 - Priority review granted based on positive results from two Phase 3 trials; if approved, Dupixent would be ...
21 February 2024 - Prescription Drug User Fee Act date is 21 June 2024. ...
20 February 2024 - Avidity Biosciences today announced that the US FDA has granted rare paediatric disease designation to AOC 1044, ...
21 February 2024 - Regeneron Pharmaceuticals today announced that the US FDA has accepted for priority review the biologics license application ...
20 February 2024 - Prescription Drug User Fee Act target action date is 21 June 2024. ...
20 February 2024 - Acceptance based on results from the pivotal Phase 3 NRG-GY018 trial. ...