USFDA

U.S. Food and Drug Administration (FDA) has accepted BMS's filing and review a supplemental Biologics License Application (sBLA) for the Opdivo (nivolumab)+Yervoy (ipilimumab) regimen to include clinical data from CheckMate -067, a landmark trial in patients with previously untreated advanced melanoma. The FDA also granted Priority Review for this application with a target action date of January 23, 2016.

US Food and Drug Administration (FDA) has approved Novonordisk's Tresiba® and Ryzodeg® 70/30 for the treatment of diabetes mellitus in adults after review of the class II resubmissions of the New Drug Applications (NDAs).

A panel of experts from the U.S. Food and Drug Administration’s (FDA) Medical Devices Advisory Committee discussed considerations to help ensure the continued safe and appropriate use of Essure® permanent birth control. While there was agreement among the Panel members that Essure is an important contraceptive option, the Panel provided input and guidance for the FDA and Bayer to consider. Based on information presented during this meeting, the Advisory Panel discussed a number of considerations including clinical research, patient education and counseling. The Panel also discussed training and certification of physicians; and post-procedural patient management including removal of the device.

Jubilant Life Sciences Ltd, an integrated global pharmaceuticals company, has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (FDA) for zolmitriptan orally disintegrating tablets, 2.5 mg and 5 mg the generic version of Zomig-ZMT (AstraZeneca), which is used for acute treatment of migraine headaches in adults.

Granules India, a Rs. 1,200 crore pharmaceutical major from Hyderabad, has received US FDA approval for ibuprofen tablets USP, 400 mg, 600 mg and 800 mg.

The US Food and Drug Administration (USFDA) has approved Aurobindo Pharma to market generic version of Prilosec delayed-release capsules used to treat ulcer.

The US Food and Drug Administration (FDA) has accepted leading global pharmaceutical company, Teva Pharmaceutical Industries Ltd's New Drug Application (NDA) for SD-809 (deutetrabenazine) for the treatment of chorea associated with Huntington disease (HD). It is  a rare and fatal neurodegenerative disorder caused by the progressive breakdown of nerve cells in the brain that affects about five to seven people per 100,000 in western countries, according to the World Health Organisation.

focus in the areas of pain management and addiction medicine, announced the approval by the US Food and Drug Administration (FDA) of a Supplemental New Drug Application (sNDA) for a new formulation of Onsolis (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant. Onsolis is separately licensed by BDSI in Taiwan and South Korea.

Ajanta Pharma Limited, a Rs.1,450 crore plus Mumbai based specialty focused pharmaceutical formulation company, has received final approval from the United States Food and Drug Administration (FDA)  for its 3 Abbreviated New Drug Applications (ANDAs), montelukast tablets, 10mg,  montelukast sodium chewable tablets, 4mg & 5mg and montelukast oral granules.