31 October 2022 - PDUFA target action date is 30 April 2023. ...
27 October 2022 - AVR-RD-02 has previously received fast track status from FDA, orphan drug designation in the US and EU, ...
26 October 2022 - PDUFA target action date is 26 April 2023, with anticipated launch soon thereafter. ...
24 October 2022 - Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy ...
12 October 2022 - Regeneron Pharmaceuticals today announced the US FDA has accepted for priority review the supplemental biologics license application ...
11 October 2022 - Eligo Bioscience today announced the US FDA has granted orphan drug designation and rare paediatric disease designation ...
11 October 2022 - Supplemental biologics license application based on statistically significant and clinically meaningful overall survival and progression-free survival results ...
28 September 2022 - CRISPR Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to CTX130, ...
28 September 2022 - The FDA has assigned a PDUFA goal date of 29 March 2023 for the NDA submission based ...
22 September 2022 - Rare paediatric disease designation qualifies Oncoheroes to receive fast track review, and a priority review voucher at ...
20 September 2022 - Assigned PDUFA target action date of 22 March 2023. ...
20 September 2022 - AVR-RD-04 has previously received orphan drug designation from FDA and EMA. ...
19 September 2022 - FDA has set action date of 19 January 2023 . ...
16 September 2022 - Radiopharm Theranostics has been granted rare paediatric disease designation by the US FDA for its DUNP19 ...
15 September 2022 - Aro Biotherapeutics today announced that the US FDA granted rare paediatric drug designation for ABX1100, an investigational ...