GTx Submits New Drug Application for Toremifene 80 mg for the Prevention of Bone Fractures in Men with Prostate Cancer ... (Centre Daily Times)
GTx, Inc. (Nasdaq: GTXI) today announced the submission of a New Drug Application with the U.S. Food and Drug Administration (FDA) for toremifene 80 mg, an oral selective estrogen receptor modulator (SERM), for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy (ADT).

FDA Advisory Committee Unanimously Recommends Approval For New Ophthalmic Product Enabled By InSite's DuraSite ... (Medical News Today)
InSite Vision Incorporated (AMEX:ISV) announced that the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to recommend approval of Bausch & Lomb's besifloxacin ophthalmic suspension, 0.6%, for the treatment of bacterial conjunctivitis, a product that utilizes InSite Vision's DuraSite patented drug delivery system.