BioSpace News Archive

Policy

Complete Response Letter Issued from U.S. FDA for Investigational Long-Acting HIV Regimen

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration has issued a complete response letter in response to ViiV Healthcare’s New Drug Application for the two-drug long-acting injectable regimen of ViiV’s cabotegravir and Janssen’s rilpivirine for the treatment of HIV-1 infection in adults.

December 21, 2019
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4 min read
Policy

ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, received a complete response letter from the US Food and Drug Administration regarding its application for cabotegravir and rilpivirine long-acting regimen for treatment of HIV-1 infection in virologically suppressed adults..

December 21, 2019
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2 min read
FDA Grants Avatrombopag Orphan Drug Designation for the Treatment of Chemotherapy-induced Thrombocytopenia

Dova Pharmaceuticals, Inc., a wholly owned subsidiary of Swedish Orphan Biovitrum AB has been granted Orphan Drug Designation[1] by the US Food and Drug Administration for avatrombopag for the potential treament of Chemotherapy-Induced Thrombocytopenia.

December 21, 2019
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4 min read