USFDA

REGENXBIO Inc.  a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy,  announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to RGX-111, the Company’s investigational gene therapy product candidate for the treatment of mucopolysaccharidosis Type I (MPS I).

Amarantus Bioscience Holding Inc. , a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, announced that it has requested Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) to treat GCMN with Engineered Skin Substitute (ESS). It is estimated that the incidence of GCMN, a rare dermatological condition present at birth, is between 8 and 80 births annually in the United States.

Drug major Lupin has received US health regulator's approval to market Fyavolv tablets, used to treat postmenopausal osteoporosis, in the American market. The company has received received the final approval from the United States Food and Drug Administration (FDA) to market Fyavolv tablets, Lupin today said in a statement.

Exelixis, Inc. announced that it has completed the submission of its rolling New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy. Exelixis has requested Priority Review as part of the NDA filing.

LabStyle Innovations Corp., developer of the Dario Diabetes Management Solution, announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for the Dario Blood Glucose Monitoring System, including its components, the Dario Blood Glucose Meter, Dario Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario app on the Apple iOS 6.1 platform and higher.

Eagle Pharmaceuticals, Inc., a specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved Docetaxel injection, non-alcohol formula for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. Eagle entered into an exclusive licensing agreement with Teikoku Pharma USA Inc. in October 2015 to market, sell and distribute Docetaxel injection in the US.

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Famotidine Tablets USP, 20 mg and 40 mg.

Sanofi Pasteur, the vaccines division of Sanofi, announced  that the Philippines have granted marketing approval to Dengvaxia®, making it the first vaccine to be licensed for the prevention of dengue in Asia.

U.S. Food and Drug Administration approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation. Uptravi is marketed by San Francisco-based Actelion Pharmaceuticals US, Inc.

The U.S. Food and Drug Administration approved Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body. Zurampic is manufactured by AstraZeneca Pharmaceuticals LP, based in Wilmington, Delaware.