Drugs in the Pipeline
Nitto Denko announced that the FDA has granted two Fast Track designations to ND-L02-s0201 for the treatment of nonalcoholic steatohepatitis (NASH) liver fibrosis and hepatitis C virus (HCV) liver fibrosis.
Accu-Break Pharmaceuticals (ABP) announced that the Food & Drug Administration (FDA) has accepted for filling the New Drug Application (NDA) for Warfarin Potassium.
Janssen announced the submission of its New Drug Application (NDA) to the Food and Drug Administration (FDA) for once-daily Invokamet XR (canagliflozin/metformin extended-release) as a new treatment option for adults with type 2 diabetes mellitus as adjunct to diet and exercise to improve glycemic control.
The FDA has granted Orphan Drug designation to marizomib (Triphase Accelerator) for the treatment of malignant glioma, an aggressive form of brain cancer with a significant unmet need due to its poor prognosis.
The FDA has granted Breakthrough Therapy designation to avelumab (Merck/Pfizer) for the treatment of patients with metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer, who have progressed after at least one previous chemotherapy regimen.
The FDA has accepted for filing and granted priority review to the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab; BMS) for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
The FDA has granted Qualified Infectious Disease Product (QIDP) designation to XF-73 (exeporfinium chloride; Destiny Pharma) for the prevention of post-surgical infections caused by Staphylococcus aureus, including Methicillin-Resistant Staphylococcus aureus (MRSA).
The FDA has granted Fast Track designation to CAM2038, buprenorphine subcutaneous injection products (Braeburn/Camurus), for the treatment of opioid addiction.
The FDA has accepted for review the New Drug Application (NDA) for GoNitro (nitroglycerin; Espero) for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
The FDA has granted Orphan Drug designation to the investigational gene therapy AGIL-AS (Agilis Biotherapeutics) for the treatment of Angelman syndrome (AS).