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.

Vitrolife has received approval from the American Food and Drug Administration, so-called 510(k) clearance, for its new needle for the collection of human oocytes, Swemed Sense (patent pending), which reduces the risk of tissue damage and pain. The needle, which has previously received European approval, a so-called CE mark, and which was launched at ESHRE in 2008, has received a very positive response and publicity. Swemed Sense will now be launched in the USA.