Drugs in the Pipeline

Drugs in the Pipeline

FDA Fast Tracks Investigational Tx for Liver Fibrosis

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.

FDA to Review New Warfarin Formulation

Accu-Break Pharmaceuticals (ABP) announced that the Food & Drug Administration (FDA) has accepted for filling the New Drug Application (NDA) for Warfarin Potassium.

NDA for Extended-Release Diabetes Tx Submitted

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.

Novel Tx Granted Orphan Drug Status for Aggressive Brain Cancer

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.

Avelumab Receives Breakthrough Tx Status for Rare Skin Cancer

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.

Opdivo Granted Priority Review for Advanced Renal Cancer

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.

Novel Synthetic Drug Granted QIDP Designation for Staph Infections

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).

Buprenorphine SC Injections Fast Tracked for Opioid Addiction

The FDA has granted Fast Track designation to CAM2038, buprenorphine subcutaneous injection products (Braeburn/Camurus), for the treatment of opioid addiction.

Sublingual Nitroglycerin Powder NDA Accepted for Review

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.

FDA Grants Gene Therapy Orphan Drug Status for Rare Genetic Disorder

The FDA has granted Orphan Drug designation to the investigational gene therapy AGIL-AS (Agilis Biotherapeutics) for the treatment of Angelman syndrome (AS).