![Surviving-an-FDA-GCP-Inspection-500.jpg Surviving an FDA GCP Inspection](https://www.centerwatch.com/ext/resources/products/Surviving-an-FDA-GCP-Inspection-500.jpg?height=200&t=1605810958&width=200)
Home » Pipeline
Pipeline
October 29, 2018
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Regeneron Pharmaceuticals and Sanofi | Dupixent (dupilumab) as an add-on maintenance therapy | Moderate-to-severe asthma | Granted approval by the FDA |
Eiger BioPharmaceuticals, Inc. | lonafarnib | Hutchinson-Gilford Progeria Syndrome (HGPS or progeria) and progeroid laminopathies | Granted Rare Pediatric Disease (RPD) designation by the FDA |
Abbott | HeartMate 3™ Left Ventricular Assist Device (LVAD) | Advanced heart failure | Granted approval by the FDA |
Bristol-Myers Squibb | Combination of Opdivo and Yervoy | Peviously untreated advanced or metastatic renal cell carcinoma (RCC) | Yielded a significantly longer treatment-free survival period than sunitinib, the standard of care, in Phase III clinical trial |
Takeda Pharmaceutical Company | Investigational subcutaneous formulation vedolizumab | Moderately to severely active ulcerative colitis | Significant portion of patients in Phase III VISIBLE 1 clinical trial show achieved clinical remission |
Roche | Xofluza (baloxavir marboxil) | Flu in patients 12 years of age and older | Granted approval by the FDA |
Incyte Corporation | ruxolitinib (Jakafi®) | Acute graft-versus-host-disease (GVHD) inpatients with inadequate response to corticosteroids | FDA accepted its supplemental New Drug Application (sNDA) for priority review |
Scarless Laboratories, Inc. | Novel therapeutic peptide, SLI-F06 | Scar reduction | Granted clearance by the FDA to enter a Phase I/IIa clinical trial |
CStone Pharmaceuticals | Monoclonal antibody (mAb) CS1003 | Cancer | FDA approved company's Investigational New Drug (IND) application |
Avita Medical | RECELL® Autologous Cell Harvesting Device (RECELL® System) | Superficial partial- and mid-thickness pediatric burns, including scald injuries | Beginning of a randomized, controlled clinical trial |
Seqirus | AFLURIA® QUADRIVALENT (Influenza Vaccine) | Flu in patients six months and older | Granted approval by the FDA |
Upcoming Events
-
21Oct