FDA Accepts For Review Theravance's Complete Response Submission For Telavancin For The Treatment Of Complicated Skin ... (Medical News Today)
Theravance, Inc. (NASDAQ: THRX) announced that the U.S. Food and Drug Administration (FDA) accepted as complete for review Theravance's response to the February 2009 Complete Response letter, which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI).

OncoGenex Receives Confirmation from FDA on the Design of a Second Phase 3 Trial (T-Net British Columbia)
Vancouver, BC, April 28, 2009--(T-Net)--OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that the company has reached an agreement with the U.S. Food and Drug Administration on the design of a second Phase 3 registration trial of OGX-011, its lead product candidate targeting castrate resistant prostate cancer, via the Special Protocol Assessment process.