2 May 2025 - Today, Novo Nordisk Canada announced that Health Canada has accepted for review, under the priority review policy, ...
2 May 2025 - The FDA filing is based on the results of the Phase 3 OASIS 4 trial that evaluated ...
30 April 2025 - Atzumi is the first and only product utilising the SMART (Simple MucoAdhesive Release Technology) platform which combines ...
1 May 2025 - Cytokinetics today announced that the US FDA has extended the PDUFA action date for the New Drug ...
1 May 2025 - OKYO Pharma announces that the US FDA has granted fast track designation to urcosimod for the treatment ...
30 April 2025 - Q32 Bio today announced that the US FDA has granted fast track designation to Q32 Bio's bempikibart ...
30 April 2025 - First and only FcRn blocker approved in anti-AChR and anti-MuSK antibody positive adults and paediatric generalised myasthenia gravis. ...
29 April 2025 - Rare paediatric disease priority review voucher granted by FDA. ...
29 April 2025 - The VENTANA TROP2 (EPR20043) RxDx device is an immunohistochemistry assay combined with a digital pathology algorithm to ...
29 April 2025 - BioInvent today announces that the US FDA has granted fast track designation to BI-1808, a first-in-class ...
29 April 2025 - Incyclix Bio today announced that the US FDA has granted fast track designation for INX-315 for ...
25 February 2025 - Innorna is thrilled to announce that the US FDA has granted rare paediatric disease designation to ...
29 April 2025 - Rinvoq (upadacitinib) is now the first and only oral Janus kinase inhibitor approved for the treatment of ...
29 April 2025 - Recommendation based on AMPLIFY Phase III trial which showed Calquence combinations demonstrated statistically significant and clinically ...
28 April 2025 - Expected 10 month review; commercial preparations underway for a potential Q1 2026 launch. ...