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Human Genome Sciences Lupus Drug FDA Program Schedule Assuming the Worst Market Manipulation?
Archiwalne serie ("Kanał nieaktywny" status)
When? This feed was archived on October 21, 2023 05:48 (). Last successful fetch was on September 28, 2019 01:48 ()
Why? Kanał nieaktywny status. Nasze serwery nie otrzymały odpowiedzi od kanału przez zbyt długi czas.
What now? You might be able to find a more up-to-date version using the search function. This series will no longer be checked for updates. If you believe this to be in error, please check if the publisher's feed link below is valid and contact support to request the feed be restored or if you have any other concerns about this.
Manage episode 151514513 series 1029942
BENLYSTA has successfully met its primary endpoint in two pivotal Phase 3 trials in seropositive patients with systemic lupus erythematosus (SLE). In June 2010, HGS and GSK submitted regulatory applications seeking approval to market BENLYSTA in the United States and Europe. The FDA has granted BENLYSTA a priority review designation with a Prescription Drug User Fee Act (PDUFA) target date of December 9, 2010 – so it is possible that BENLYSTA could receive regulatory approval in the United States before the end of 2010.
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Archiwalne serie ("Kanał nieaktywny" status)
When? This feed was archived on October 21, 2023 05:48 (). Last successful fetch was on September 28, 2019 01:48 ()
Why? Kanał nieaktywny status. Nasze serwery nie otrzymały odpowiedzi od kanału przez zbyt długi czas.
What now? You might be able to find a more up-to-date version using the search function. This series will no longer be checked for updates. If you believe this to be in error, please check if the publisher's feed link below is valid and contact support to request the feed be restored or if you have any other concerns about this.
Manage episode 151514513 series 1029942
BENLYSTA has successfully met its primary endpoint in two pivotal Phase 3 trials in seropositive patients with systemic lupus erythematosus (SLE). In June 2010, HGS and GSK submitted regulatory applications seeking approval to market BENLYSTA in the United States and Europe. The FDA has granted BENLYSTA a priority review designation with a Prescription Drug User Fee Act (PDUFA) target date of December 9, 2010 – so it is possible that BENLYSTA could receive regulatory approval in the United States before the end of 2010.
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