Centocor Announces Ustekinumab Biologic License Application Accepted For Filing By FDA (Medical News Today)
Centocor, Inc. announced that the Biologics License Application (BLA) for ustekinumab (CNTO 1275) has been accepted for review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with chronic moderate to severe plaque psoriasis.

Watson Announces Silodosin NDA Accepted for Filing by FDA for the Treatment of Benign Prostatic Hyperplasia (The San Francisco Examiner)
CORONA, Calif. ( Map ) - CORONA, Calif., Feb. 12 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI ), a leading specialty pharmaceutical company, today announced that its New Drug Application (NDA) for silodosin, a novel alpha(1)- adrenoreceptor antagonist, has been accepted for filing by the U.S. Food and Drug Administration (FDA). Watson is seeking marketing approval of ...

GSK To Update FDA On HPV Vaccine Cervarix Later This Year, CEO Says (Medical News Today)
GlaxoSmithKline CEO Jean-Pierre Garnier on Thursday said that the company will provide FDA with updated information about its human papillomavirus vaccine Cervarix by the third quarter of 2008, Reuters reports. Garnier said that it is not possible to determine whether Cervarix -- which is available in Europe -- will become available on the U.S.