Pipeline
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
TERN-101 |
non-alcoholic steatohepatitis (NASH) |
Phase I trial initiated |
|
OKI-179 |
advanced solid tumors |
Phase I trial initiated |
|
nalmefene hydrochloride (HCl) |
opioid overdose |
Phase I trial initiated |
|
GFB-887 |
kidney disease |
Phase I trial initiated |
|
AKB-9778 |
primary open angle glaucoma (POAG) |
Phase Ib trial initiated enrolling 48 subjects |
|
ADO09 |
type 1 diabetes |
Phase Ib trial initiated enrolling 24 subjects in Germany |
|
TP-0903 |
previously treated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) |
Phase I/II trial initiated |
|
RUCONEST recombinant human C1 esterase inhibitor (rhC1INH) |
pre-eclampsia |
Phase I/II trial initiated |
|
ST266 |
persistent corneal epithelial defects (PEDs) |
Phase II trial initiated |
|
Ivenix Infusion System |
infusion |
510(k) clearance granted by the FDA |
|
Cor PATCH |
cardiovascular disease |
510(k) clearance granted by the FDA |
|
BBT-059 |
Acute Radiation Syndrome (ARS) |
Orphan Drug designation granted by the FDA |
|
PL-8177 |
non-infectious intermediate, posterior, pan and chronic anterior uveitis |
Orphan Drug designation granted by the FDA |
|
Rituxan (rituximab) in combination with glucocorticoids (GCC) |
granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children two years of age and older |
Priority Review granted by the FDA |
|
ResistancePlus GC |
N. gonorrhea |
Breakthrough Device designation granted by the FDA |
|
T-Guard |
steroid-refractory acute graft-versus-host disease (SR-aGVHD) |
IND approval granted by the FDA |
|
IB-Stim |
irritable bowel syndrome (IBS) in patients ages 11-18 |
Clearance granted by the FDA |
|
Polivy (polatuzumab vedotin-piiq) in combination with bendamustine plus Rituxan (rituximab) |
diffuse large B-cell lymphoma (DLBCL) |
Accelerated approval granted by the FDA |
|
KEYTRUDA |
metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) |
Approval granted by the FDA |
|
Eversense Continuous Glucose Monitoring System |
diabetes |
Approval granted by the FDA |
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