Vanda Pharmaceuticals Announces Receipt Of Not Approvable Letter From FDA For Iloperidone (Medical News Today)
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced the receipt of a not approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application for iloperidone, an investigational atypical antipsychotic that was reviewed for the treatment of schizophrenia.

Osteotech's Plexur M(TM) Biocomposite Receives FDA Clearance In Spine (Medical News Today)
Osteotech, Inc. (Nasdaq: OSTE), a leader in the emerging field of biologic solutions for regenerative healing, announced that the United States Food and Drug Administration ("FDA") has cleared its 510(k) submission for Plexur M(TM) Biocomposite for use in spinal applications.

NexMed Receives FDA Response For Erectile Dysfunction Product (Medical News Today)
NexMed, Inc. (Nasdaq: NEXM), announced the receipt of a non approvable letter from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for its topical treatment for erectile dysfunction (ED). The major regulatory issues raised by the FDA were related to the results of the transgenic mouse carcinogenicity study which NexMed completed in 2002.