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RSS FeedPosted by Michael Wonder on 16 Apr 2026
Opna Bio announces fast track designation granted to OPN-6602 for the treatment of multiple myeloma
15 April 2026 - Opna Bio today announced that the US FDA has granted fast track designation to OPN-6602, a dual ...
Posted by Michael Wonder on 16 Apr 2026
Arbutus receives US FDA fast track designation for imdusiran for the treatment of chronic hepatitis B
15 April 2026 - Arbutus Biopharma today announced that the US FDA has granted fast track designation for imdusiran for the ...
Posted by Michael Wonder on 15 Apr 2026
Aligos Therapeutics announces first interim analysis results from the Phase 2 B-SUPREME study of pevifoscorvir sodium in participants with chronic hepatitis B virus infection and grant of FDA fast track designation
14 April 2026 - Aligos Therapeutics today announced the first interim analysis results of the Phase 2 B-SUPREME study of pevifoscorvir ...
Posted by Michael Wonder on 15 Apr 2026
Renaissance Pharma secures FDA fast track designation for daretabart (hu1418K322A) in high risk neuroblastoma
14 April 2026 - Renaissance Pharma Limited, an Essential Pharma company, today announces that the US FDA has granted fast track ...
Posted by Michael Wonder on 14 Apr 2026
Kymera Therapeutics announces US FDA fast track designation for KT-621, a first in class, oral STAT6 degrader for the treatment of moderate to severe asthma
13 April 2026 - Kymera Therapeutics today announced that the US FDA has granted fast track designation to KT-621, its ...
Posted by Michael Wonder on 10 Apr 2026
Celltrion’s ADC candidate CT-P71 wins FDA fast track in urothelial cancer
9 April 2026 - Celltrion announced Thursday that the US FDA has granted fast track designation to its antibody-drug conjugate ...
Posted by Michael Wonder on 07 Apr 2026
NextCure receives fast track designation for SIM0505 (CDH6 ADC) in ovarian cancer
7 April 2026 - NextCure today announced that the US FDA has granted fast track designation for SIM0505 for the ...
Posted by Michael Wonder on 07 Apr 2026
Climb Bio announces FDA fast track designation for budoprutug for the treatment of primary membranous nephropathy
7 April 2026 - Climb Bio today announced that the US FDA has granted fast track designation to budoprutug, the company’s ...
Posted by Michael Wonder on 03 Apr 2026
Context Therapeutics announces CTIM-76 receives FDA fast track designation for the treatment of platinum-resistant ovarian cancer
2 April 2026 - Context Therapeutics today announced that the US FDA has granted fast track designation to CTIM-76, a ...
Posted by Michael Wonder on 02 Apr 2026
Cocrystal Pharma receives FDA fast track designation for CDI-988 for norovirus infection treatment and preventive
2 April 2026 - Cocrystal Pharma announces that the US FDA has granted fast track designation to its oral, direct-acting ...
Posted by Michael Wonder on 02 Apr 2026
Pasithea Therapeutics announces grant of fast track designation by FDA to PAS-004 for treatment of neurofibromatosis type 1 associated plexiform neurofibromas causing significant morbidity
1 April 2026 - Pasithea Therapeutics today announced that the US FDA has granted fast track designation to PAS-004 for ...
Posted by Michael Wonder on 02 Apr 2026
A2 Biotherapeutics receives US FDA fast track designation for A2B543, a logic-gated CAR T-cell therapy enhanced with a membrane-tethered IL-12 booster
1 April 2026 - A2 Biotherapeutics today announced that the US FDA has granted fast track designation for A2B543, an autologous ...
Posted by Michael Wonder on 31 Mar 2026
Zymeworks receives US FDA fast track designation for ZW191, a folate receptor alfa targeting antibody drug conjugate
30 March 2026 - Zymeworks today announced that the US FDA has granted fast track designation to ZW191, an antibody ...
Posted by Michael Wonder on 25 Mar 2026
Triana Biomedicines’ TRI-611 granted US FDA fast track designation for treatment of ALK positive non-small cell lung cancer
25 March 2026 - Triana Biomedicines today announced that the US FDA granted fast track designation for TRI-611, an investigational molecular ...
Posted by Michael Wonder on 19 Mar 2026
Remix Therapeutics granted FDA fast track designation for REM-422 for the treatment of recurrent, metastatic or unresectable adenoid cystic carcinoma
19 March 2026 - Remix Therapeutics today announced that the US FDA has granted fast track designation to first-in-class small molecule ...