US Food and Drug Administration customer service

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US Food and Drug Administration customer service news

US Food and Drug Administration Approves Prior Approval Supplement for Commercial Launch of Portola ...

SOUTH SAN FRANCISCO, Calif., Dec. 19, 2017 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc.® (NASDAQ:PTLA) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Prior Approval Supplement (PAS) for Bevyxxa ...


US Food and Drug Administration Grants CLIA Waiver for Alere Determine™ HIV-1/2 Ag/Ab Combo Test

Alere Inc. (NYSE: ALR), a global leader in rapid diagnostic tests, today announced that the U.S. Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) Waiver for the Alere Determine™ HIV-1/2 Ag/Ab Combo ...


US Food and Drug Administration

The today approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer. HER2 is a protein involved in normal cell growth. It is found in increased amounts on some types of cancer ...

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