25 June 2025 - Precision BioSciences today announced that the US FDA has granted rare paediatric disease designation for PBGENE-DMD for ...
24 June 2025 - Quoin Pharmaceuticals today announced that the US FDA has granted rare paediatric disease designation for the ...
24 June 2025 - With this approval, paediatric patients aged five years and older with active lupus nephritis will have ...
17 June 2025 - Supported by 52 week data from the Phase 3 UNITI-Jr study, submission aims to expand Stelara indication ...
15 June 2025 - Approval of 45 mg/0.5 mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for ...
5 June 2025 - Exclusive licensing partner Santen will commercialise SYD-101 under the brand name Ryjunea in the EU. ...
2 June 2025 - Children immunised with the antibody nirsevimab are significantly less likely to develop RSV-related lower respiratory tract infections. ...
2 June 2025 - Ascendis Pharma today announced that the US FDA has accepted for priority review its new drug application ...
27 May 2025 - Ocugen today announced that the US FDA has granted rare paediatric disease designation for OCU410ST for the ...
22 May 2025 - Relief Therapeutics today announced that the US FDA has granted rare paediatric disease designation to RLF-TD011 ...
19 May 2025 - Bayer announced that the US FDA has approved Jivi, a recombinant DNA-derived, extended half-life factor VIII ...
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 ...
14 May 2025 - FDA grants priority review of application, with PDUFA target action date of 12 September 2025. ...
8 May 2025 - ALK today announced that Health Canada has approved ALK’s regulatory filing for Itulatek (tree pollen sublingual allergy ...