Article: The FDA granted priority review status to Wyeth's NDA.(Pipeline)

Article: BLA for Aldurazyme accepted by FDA, granted ...
Biotech Week;  November 6, 2002 ;     693 words ... ... biologics license application (BLA) filing for Aldurazyme, and has granted the application priority review status. Priority review status specifies that the FDA will respond to the filing within 6 months from the date of the completed BLA ...

Article: FDA Assigns 'Priority Review' Status to ENBREL(R) ...
PR Newswire;  September 17, 2001 ;     700+ words ... ... S. Food and Drug Administration (FDA) granted "priority review" status for Immunex's supplemental Biologics ... assigned the ENBREL sBLA a "priority review" status. Priority review status indicates that the FDA is to act on ...

Article: FDA Grants Expedited Review Status to Cyberonics' ...
PR Newswire;  July 26, 1999 ;     700+ words ... ... and Drug Administration (FDA) granted Expedited Review status for a future Premarket Approval ... disorder. FDA grants Expedited Review status in order to provide for more ... conditions. FDA grants Expedited Review status to devices which are intended ...

Article: Lifecore anti-adhesion product wins expedited review ...
Biomedical Materials;  June 1, 1999 ;     484 words ...Lifecore Biomedical Inc has won expedited review status from the US Food and Drug Administration (FDA ... application for premarket approval (PMA). The FDA granted the expedited review status based on the potential for an adhesion prevention ...

Article: Cygnus Granted Expedited Review Status by FDA for ...
PR Newswire;  November 6, 2001 ;     700+ words ... ... has been granted expedited review status. Granting of expedited review status means that this supplemental ... We are very pleased the FDA granted us expedited review because ... submissions that receive expedited review status. In some cases, you can ...

Article: GlucoWatch Biographer Gets Expedited Review Status ...
Diabetes Week;  December 10, 2001 ;     681 words ... ... ages 7-17) has been granted expedited review status. Granting of expedited review status means that this supplemental application ... applications. "We are very pleased the FDA granted us expedited review because, as their notification ...

Article: FDA ASSIGNS PRIORITY REVIEW STATUS TO ...
Biotech Business;  May 1, 2001 ;     700+ words ... ... Administration (FDA) that priority review status has been assigned to Schering ... considered filed with priority review status. Priority review status provides for FDA action within ... On January 19, 2001, the FDA granted marketing approval to PEG ...