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Pipeline
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Peloton Therapeutics, Inc. | PT2977 (oral HIF-2α inhibitor) | Treatment of von Hippel-Linau (VHL) disease-associated kidney cancer | Phase II trial initiated enrolling 50 subjects in the U.S. |
Viking Therapeutics, Inc. | VK2809 | Primary hypercholesterolemia and non-alcoholic fatty liver desease (NAFLD) | Phase II trial initiated |
Tricida, Inc. | TRCA-301 | chronic kidney disease patients with metabolic acidosis | Phase III trial initiated enrolling 217 subjects in the U.S. and Europe |
Janssen (part of Johnson & Johnson) | esketamine nasal spray | adults with treatment-resistant depression | Phase III trial initiated |
Camber Spine Technologies | ENZA (Titanium Anterior Lumbar Interbody Fusion (ALIF) system | autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 | 510(k) clearance granted by the FDA |
Royal Philips | Ingenia Elition 3.0T MR solution | increased diagnostic performance | 510(k) clearance granted by the FDA |
Partner Therapeutics, Inc. | Leukine | adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrom of Acute Radiation Syndrome) | Approval granted by the FDA |
Mylan | Fulphila (pegfilgrastim-jmbd) | febrile neutropenia | Approval granted by the FDA |
Eli Lilly and Incyte Corporation | OLUMIANT (baricitnib) | adults with moderately-to-severely active Rheumatoid Arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies | Approval granted by the FDA |
Micronics, Inc. | PanNAT STEC Test | Shiga toxin-producing E. Coli (STEC) | Clearance granted by the FDA |
Chugai Pharmaceutical Co., Ltd. | HEMLIBRA (U.S. generic name: emicizumab-kxwh) | adults and children with hemophilia A without factor VIII inhibitors | Priority Review Designation granted by the FDA |
Pfizer | Talazoparib | germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer (MBC) | Priority Review Designation granted by the FDA |
Pfizer | Xalkori (crizotinib) | relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive | Breakthrough Therapy Designation granted by the FDA |
AutoGenomics, Inc. | INFINITI Neutral Response Panel | opioid dependency | Breakthrough Device Designation granted by the FDA |
Curis, Inc. | fimepinostat (CUDC-907) | relapsed or fractory (R/R) diffuse large B-cell lymphoma (DLBCL) | Fast Track Designation granted by the FDA |
Alnylam Pharmaceuticals, Inc. | ALN-TTRsc02 | Transthyretin-mediated amyloidosis | Orphan Drug Designation granted by the FDA |
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