FDA fast track designation supports expedited development and regulatory interaction for BBO-11818 in advanced KRAS-mutant ...
Debiopharm ( a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow's standard of care to cure cancer and infectious diseases, today announced that the U.S. Food and ...
Following the March 2026 grant of FTD to PLX-200 in treatment of Late-Infantile Neuronal Ceroid Lipofuscinosis (LINCL/CLN2 disease), PLX-200 now holds FTD for all four prospective indications to be ...
Fast Track designation has the potential to facilitate development and accelerate FDA review of imdusiran WARMINSTER, Pa., April 15, 2026 ...
Polaryx Therapeutics has now been granted fast track designation by the Food and Drug Administration for all four indications it is testing with its lead drug candidate. The last FDA decision adds ...
Arbutus Biopharma Corporation (NASDAQ:ABUS) shares climbed 6% on Wednesday after the company revealed it had received Fast ...
Arbutus Biopharma Corporation (NASDAQ:ABUS) shares rose 6% Wednesday after the company announced it received Fast Track designation from the U.S. Food and Drug Ad ...
Fast Track status enables closer FDA engagement to potentially accelerate development of a CDH6-directed ADC in ...
The Dermatology Division of the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) in moderate-to-severe palmoplantar pustulosis (PPP) supported by ...
MELBOURNE, Australia and NEW YORK, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, announces ...
FDA fast track designation supports development of pelareorep plus bevacizumab/FOLFIRI in 2L KRAS-mutant MSS mCRC, enabling more frequent regulatory engagement and potential accelerated pathways.
Add Yahoo as a preferred source to see more of our stories on Google. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29 ...
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