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Upcoming Meetings

Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsCardiovascular and Renal Drugs Advisory Committee Meeting

Meeting Date: 7/15/20-1/15/20

Meeting Details:

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On July 15, 2020, the committee will be asked to discuss new drug application (NDA) 22231, terlipressin, lyophilized powder for solution for injection,submitted by Mallinckrodt Pharmaceuticals, for the proposed indication of treatment of hepatorenal syndrome Type 1.

 

       
Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 9:00AM-5:00PM    
Materials:
   
       

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Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 7/14/20-7/14/20

Meeting Details:

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On July 14, 2020, the committee will discuss biologic license application (BLA) 761158, for belantamab mafodotin, submitted by GlaxoSmithKline Intellectual Property Development Ltd. England. The proposed indication (use) for this product is for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

 

       
Location: TelCon | Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 9:00AM-1:30PM    
Materials:
   
       

View Meeting Details / News

Meeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs Advisory Committee

Meeting Date: 7/14/20-7/14/20

Meeting Details:

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On July 14, 2020, the committee will discuss biologic license application (BLA) 761158, for belantamab mafodotin, submitted by GlaxoSmithKline Intellectual Property Development Ltd. England. The proposed indication (use) for this product is for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

 

       
Location: TelCon | Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Related News Links: Not Available
Time: 9:00AM-1:30AM    
Materials:
   
       

View Meeting Details / News

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