30 August 2023 - To ensure the most efficient regulatory process, the review by the US FDA will be conducted in ...
29 August 2023 - Bloomsbury Genetic Therapies Limited announced today that the US FDA has granted rare paediatric disease designation for ...
23 August 2023 - If approved, Xtandi would become the first and only novel hormone therapy approved in this earlier ...
21 August 2023 - Krystal Biotech announced that it has completed the sale of its rare paediatric disease priority review ...
18 August 2023 - Calliditas Therapeutics today announced that the US FDA has accepted the submission for the supplemental new ...
15 August 2023 - Submission supported by comprehensive clinical data package, including updated results that demonstrate durable remissions and an ...
14 August 2023 - LCTG-001 on course to be the first FDA approved biologic from human milk. ...
7 August 2023 - HG004 is a one time, direct to RPE treatment of inherited retinal disease caused by mutations in ...
3 August 2023 - Aardvark's Phase 2 trial of oral ARD-101 in young adults with Prader-Willi syndrome is now open ...
31 July 2023 - Kinnear Pharmaceuticals today announced the US FDA has granted qualified infectious disease product designation for CSA-131 ...
20 July 2023 - Advent plans FDA PDUFA meeting late 2023 to establish pathway for US approval of lead injectable ...
12 July 2023 - QIDP designation for biologics provides FDA priority review status. ...
10 July 2023 - The US FDA granted a rare paediatric Disease designation to MyoPax.. ...
7 July 2023 - NS Pharma announced today the US FDA has granted rare paediatric disease designation to NS-089/NCNP-02 (brogidirsen) an ...
6 July 2023 - Marks third rare paediatric drug designation granted by FDA for pipeline candidate. ...