24 July 2025 - Sprout Pharmaceuticals today announced that the US FDA has granted priority review for its supplemental application ...
22 July 2025 - Accelerated drug review for companies supporting US national interests. ...
17 July 2025 - -- Rocket Pharmaceuticals today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
16 July 2025 - Genascence Corporation today announced that the US FDA has granted the regenerative medicine advanced therapy designation ...
17 July 2025 - New drug application supported by results from the Phase 2b SunRISe-1 study. ...
15 July 2025 - Taxis Pharmaceuticals announced today that it has received an FDA qualified infectious disease product designation for TXA14007, ...
7 July 2025 - FDA assigns PDUFA target action date of 5 January 2026, for decision on accelerated approval. ...
30 June 2025 - Minovia Therapeutics announces that the US FDA has granted fast track designation to the Company’s lead investigational ...
25 June 2025 - Precision BioSciences today announced that the US FDA has granted rare paediatric disease designation for PBGENE-DMD for ...
25 June 2025 - enGene Holdings today announced that the US FDA has granted regenerative medicine advanced therapy designation to detalimogene ...
23 June 2025 - Novadip Biosciences is developing NVD003, an autologous therapy derived from adipose stem cells, as a potential ...
24 June 2025 - Quoin Pharmaceuticals today announced that the US FDA has granted rare paediatric disease designation for the ...
24 June 2025 - Syndax Pharmaceuticals today announced that the US FDA has granted priority review for its supplemental new drug ...
17 June 2025 - The US FDA today announced its Commissioner’s National Priority Voucher program to enhance the health interests of ...
18 June 2025 - Bavarian Nordic announced today that it has entered into an agreement to sell its priority review ...