Expedited Approval Pathways
Spot drugs moving faster through approval with Priority Review, Breakthrough Therapy, Accelerated Approval, and Fast Track.
Context Therapeutics Inc.
Context Therapeutics Inc. received Fast Track designation for CTIM-76 for the treatment of platinum-resistant ovarian cancer in patients that have received all standard of care therapies on Apr 2, 2026.
| Brand | Ingredient | Designation | Designation Date | Indication |
|---|---|---|---|---|
| CTIM-76 | CLDN6 x CD3 T cell engaging bispecific antibody | Fast Track | Apr 2, 2026 | Platinum-resistant ovarian cancer in patients that have received all standard of care therapies |
Active Clinical Trial Details
Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. received Fast Track designation for CDI-988 for the treatment of Norovirus infection on Apr 2, 2026.
| Brand | Ingredient | Designation | Designation Date | Indication |
|---|---|---|---|---|
| CDI-988 | Oral protease inhibitor | Fast Track | Apr 2, 2026 | Norovirus infection |
Active Clinical Trial Details
FORE Biotherapeutics
FORE Biotherapeutics received Breakthrough Therapy designation for plixorafenib for the treatment of BRAF V600E-mutated high-grade glioma (HGG) on Apr 1, 2026.
| Brand | Ingredient | Designation | Designation Date | Indication |
|---|---|---|---|---|
| Plixorafenib | Plixorafenib | Breakthrough Therapy | Apr 1, 2026 | BRAF V600E-mutated high-grade glioma (HGG) |
A2 Biotherapeutics, Inc.
A2 Biotherapeutics, Inc. received Fast Track designation for A2B543 for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumors on Apr 1, 2026.
| Brand | Ingredient | Designation | Designation Date | Indication |
|---|---|---|---|---|
| A2B543 | Autologous logic-gated CAR T-cell therapy enhanced with a membrane-tethered IL-12 booster | Fast Track | Apr 1, 2026 | Germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumors |
Active Clinical Trial Details
Pasithea Therapeutics Corp.
Pasithea Therapeutics Corp. received Fast Track designation for PAS-004 for the treatment of Neurofibromatosis Type 1 (NF1)-associated plexiform neurofibromas (PN) on Apr 1, 2026.
| Brand | Ingredient | Designation | Designation Date | Indication |
|---|---|---|---|---|
| PAS-004 | Macrocyclic MEK inhibitor | Fast Track | Apr 1, 2026 | Neurofibromatosis Type 1 (NF1)-associated plexiform neurofibromas (PN) |
Active Clinical Trial Details
Zymeworks Inc.
Zymeworks Inc. received Fast Track designation for ZW191 for the treatment of advanced or metastatic platinum-resistant ovarian cancer on Mar 30, 2026.
| Brand | Ingredient | Designation | Designation Date | Indication |
|---|---|---|---|---|
| ZW191 | FRα-targeting antibody-drug conjugate | Fast Track | Mar 30, 2026 | Advanced or metastatic platinum-resistant ovarian cancer |
Active Clinical Trial Details
TRIANA Biomedicines, Inc.
TRIANA Biomedicines, Inc. received Fast Track designation for TRI-611 for the treatment of ALK-positive non-small cell lung cancer on Mar 25, 2026.
| Brand | Ingredient | Designation | Designation Date | Indication |
|---|---|---|---|---|
| TRI-611 | Molecular glue degrader | Fast Track | Mar 25, 2026 | ALK-positive non-small cell lung cancer |
Active Clinical Trial Details
Biogen Inc.
Biogen Inc. received Breakthrough Therapy designation for litifilimab (BIIB059) for the treatment of cutaneous lupus erythematosus (CLE) on Jan 28, 2026.
| Brand | Ingredient | Designation | Designation Date | Indication |
|---|---|---|---|---|
| Litifilimab (BIIB059) | Humanized IgG1 monoclonal antibody targeting BDCA2 | Breakthrough Therapy | Jan 28, 2026 | Cutaneous lupus erythematosus (CLE) |
Active Clinical Trial Details
Eli Lilly and Company
Eli Lilly and Company received Breakthrough Therapy designation for sofetabart mipitecan (LY4170156) for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in adult patients who have received prior bevacizumab and mirvetuximab soravtansine if eligible on Jan 20, 2026.
| Brand | Ingredient | Designation | Designation Date | Indication |
|---|---|---|---|---|
| Sofetabart mipitecan (LY4170156) | Folate receptor alpha (FRα) antibody-drug conjugate (ADC) | Breakthrough Therapy | Jan 20, 2026 | Platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in adult patients who have received prior bevacizumab and mirvetuximab soravtansine if eligible |
Active Clinical Trial Details