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Gilead expands FDA label for Biktarvy with Phase I pregnant HIV patient data

Gilead Sciences has received a US Food and Drug Administration (FDA) approval for the label expansion of its human immunodeficiency virus -1 (HIV-1) fixed combination therapy, Biktarvy (bictegravir ...
Monthly Prescribing Reference

Biktarvy Label Update Adds Data on Safety, Efficacy in Pregnant HIV Patients

No new safety or tolerability concerns were observed with Biktarvy during pregnancy and postpartum. The Food and Drug Administration (FDA) has approved updated labeling for Biktarvy ® (bictegravir ...
Drug Store News

Gilead settles Biktarvy patent disputes

Gilead has settled patent disputes with three generic companies for Biktarvy, per a Yahoo Finance report. Gilead settlement agreements are with Lupin, Cipla and Laurus Labs, who had filed abbreviated ...
Nasdaq

FDA Approves Biktarvy® Label Update With Data for Pregnant Adults With HIV

– Perinatal Guidelines Recognize Biktarvy as Alternative Regimen for Use During Pregnancy and for Those Trying to Conceive – The updated label now includes additional data from Study 5310, a Phase 1b, ...
FiercePharma

J&J, GSK's ViiV tout switching study showing patients prefer their long-acting HIV med Cabenuva over Gilead rival

To make Cabenuva the standard treatment option for HIV, Johnson & Johnson and GSK-owned ViiV Healthcare must first dethrone Gilead Sciences’ once-daily stalwart Biktarvy. Now, the partners have a ...