Direct-Acting Antivirals Slapped With Black Box On Hepatitis B Risk
FDA imposes boxed warning on labels for hepatitis C drugs in response to reports of hepatitis B reactivation, including fatal cases.
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AbbVie Might Be Most Affected By FDA’s HCV Drug Safety Warning
A US FDA warning of serious liver injuries in hepatitis C patients treated with combo pills from AbbVie, Gilead and Merck may impact AbbVie's Mavyret most, since it's one of the company's top sellers.
Gilead Completes HCV Clinical Development With Vosevi Approval
Bringing three-drug, single-tablet regimen to market means Gilead has an answer for every hepatitis C patient, company says. It still lacks an answer, however, for its future business direction as HCV revenue wanes.
EMA Committee Urges Warning About Hep B Reactivation In Patients Taking DAAs
The European Medicines Agency’s pharmacovigilance committee wants manufacturers of the direct-acting antivirals for hepatitis C to include a warning about the possibility of hepatitis B reactivation in patients who carry both viruses.