Gilead Sciences, Inc has received a response from the US Food and Drug Administration (FDA) to its appeal, submitted under the formal Dispute Resolution process, regarding the Agency's Complete Response Letter for its New Drug Application (NDA) for aztreonam for inhalation solution.

The US Food and Drug Administration (US FDA) approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with severe obsessive-compulsive disorder (OCD).

GTx, Inc. announced that the United States Food and Drug Administration has accepted for filing and review the New Drug Application (NDA) for toremifene 80 mg, an oral selective estrogen receptor modulator, which GTx seeks to market for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy (ADT).

Hyderabad-based drug maker Aurobindo Pharmaceuticals said in a filing with the Bombay Stock Exchange that has received temporary approval for Tenofovir Disoproxil Fumarate tablets, 300 mg from the US Food and Drug Administration.