BENGALURU: GlaxoSmithKline's HIV drugs division ViiV Healthcare said on Saturday that the U.S. Food and Drug Administration declined to approve its long acting HIV injection.
ViiV, in which Pfizer and Shionogi have small stakes, said it received a so-called complete response letter (CRL) from the FDA in which the regulator questioned the treatment's chemistry, manufacturing and controls process, but not its safety.
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