14 May 2025 - Kaerus Bioscience today announces that its lead candidate KER-0193 has been granted both orphan drug designation and ...
15 May 2025 - BrainChild Bio advancing BCB-276 towards BLA submission with a single pivotal Phase 2 trial planned to ...
13 May 2025 - FDA assigns PDUFA target action date of 9 November 2025. ...
9 May 2025 - This RMAT designation is based on data from 3 clinical studies demonstrating the potential benefit of AAV-GAD ...
2 May 2025 - Today, Novo Nordisk Canada announced that Health Canada has accepted for review, under the priority review policy, ...
25 February 2025 - Innorna is thrilled to announce that the US FDA has granted rare paediatric disease designation to ...
14 April 2025 - Fate Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to FT819, an ...
1 April 2025 - PDUFA target action date is 28 July 2025. ...
1 April 2025 - GRIN Therapeutics today announced that the EMA has granted Priority Medicine (PRIME) designation to radiprodil, the company's ...
25 March 2025 - Tolebrutinib was granted breakthrough therapy designation by the FDA based on positive results from the HERCULES Phase ...
17 March 2025 - Regulatory submission is based on positive results from the Phase 3 FINEARTS-HF study, which is part of ...
12 March 2025 - Marks third FDA designation for ATSN-201, which has also received rare paediatric disease designation and orphan drug ...
4 March 2025 - FDA assigns PDUFA target action date of 31 August 2025. ...
27 February 2025 - Regenerative medicine advanced therapy designation follows clinical data of absolute lymphocyte count and significant overall survival correlations ...
27 February 2025 - Sobi today announced that the US FDA has accepted the supplemental biologics license application for Gamifant (emapalumab-Izsg) ...