Article: Fusion inhibitor granted priority review status by FDA.

Article: FUZEON(TM) Granted Priority Review Status by ...
PR Newswire;  October 11, 2002 ;     700+ words ... ... Application (NDA) for FUZEON(TM) (generic ... has been granted priority review status. Designed ... inhibitors." The priority review designation establishes ... period for the FUZEON NDA, which was ... The granting of priority review status by the FDA ... milestone in bringing ...

Article: T-20 (FUZEON) gets priority review.(Brief ...
AIDS Treatment News;  October 18, 2002 ;     607 words ...On October 11 Roche and Trimeris, Inc. announced that the FDA had granted priority review to FUZEON (TM) (generic name enfuvirtide, formerly known as T-20). This means that the FDA plans to review the application for approval ...

Article: U.S. FDA Approves FUZEON(TM); First Drug to Block Entry of ...
PR Newswire;  March 13, 2003 ;     700+ words ... ... Trimeris, Inc. announced today that FUZEON(TM) (enfuvirtide), a novel ... FDA) following a six-month priority review. FUZEON in combination with other antiretroviral ... ongoing antiretroviral therapy. FUZEON is the first fusion inhibitor ...

Article: Second Pivotal Study Demonstrates Benefit of FUZEON(TM) ...
PR Newswire;  November 18, 2002 ;     700+ words ... ... Regulatory submissions for FUZEON were filed in the U.S. and ... other antiretroviral agents. FUZEON was granted priority review status in the U.S. in October ... that work inside the cell, FUZEON has a unique mechanism of action ...

Article: Trimeris, Roche Increase Capacity For Fuzeon, Release More ...
BIOWORLD Today;  November 4, 2009 ;     700+ words ... ... into higher gross margin for Fuzeon." All three New York-based ... received FDA approval for Fuzeon under fast-track priority review guidelines this spring. The ... European Union and Switzerland, Fuzeon is designed to work outside ...

Article: TRIMERIS, ROCHE'S FIRST-IN-CLASS HIV DRUG, FUZEON, ...
BIOWORLD Today;  March 17, 2003 ;     700+ words ... ... accelerated approval application for Fuzeon, a first-in-class fusion ... Approved under fast-track priority review guidelines, Fuzeon (enfuvirtide), in combination ... designed to work inside the cell, Fuzeon is designed to work outside ...

Article: Update on the Manufacture of Investigational HIV Drug ...
PR Newswire;  December 18, 2002 ;     700+ words ... ... immune cell. Consequently, FUZEON is active against HIV that is ... Regulatory submissions for FUZEON were filed in the U.S. and ... other antiretroviral agents. FUZEON was granted priority review status in the U.S. in October ...