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FDA approves Biktarvy label update with data for pregnant adults with HIV – Gilead Sciences

Written by | 5 May 2024

Gilead Sciences, Inc. announced the FDA approved an updated label with additional data reinforcing the safety and efficacy profile of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25… read more.

Analyses of Yescarta CAR T-cell therapy support curative potential in patients with non-Hodgkin lymphomas – Kite/Gilead Sciences

Written by | 30 Dec 2023

Kite, a Gilead Company announced data from follow-up analyses of three studies of Yescarta (axicabtagene ciloleucel) that demonstrate the long-term survival potential for patients living with several sub-types… read more.

FDA approves Veklury to treat COVID-19 in people with mild to severe hepatic impairment with no dose adjustment – Gilead Sciences

Written by | 4 Sep 2023

Gilead Sciences, Inc. announced that the FDA approved a supplemental new drug application (sNDA) for the use of Veklury (remdesivir) with no dose adjustments to treat COVID-19 in… read more.

European Commission approves Trodelvy to treat unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer patients who have received endocrine-based therapy – Gilead Sciences

Written by | 2 Aug 2023

Gilead Sciences, Inc. announced that the European Commission (EC) approved Trodelvy (sacituzumab govitecan) as a monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor… read more.

Twice-yearly lenacapavir demonstrates sustained impact on health-related quality of life in people with HIV – Gilead Sciences

Written by | 30 Jul 2023

Gilead Sciences, Inc. presented new data reinforcing the efficacy, safety, and tolerability profile of lenacapavir, including patient-reported outcomes (PRO) from the Phase II/III CAPELLA trial . These latest… read more.

FDA approves expanded indication of Biktarvy for treatment of HIV-1 in pediatric populations – Gilead Sciences

Written by | 26 Oct 2021

Gilead Sciences, Inc. announced the FDA approved a new low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing… read more.

DisCoVeRy trial of Verklury concluded there was no clinical benefit in hospitalised patients with COVID 19 – Gilead Sciences

Written by | 21 Sep 2021

A study conducted in Europe of Gilead’s Verklury (remdesivir) concluded that the antiviral provided no clinical benefit in hospitalized patients with COVID-19 compared to existing treatments . The… read more.

Four-year Biktarvy data presented at IAS 2021 demonstrate high efficacy and durable viral suppression in treatment-naïve adults with HIV – Gilead Sciences

Written by | 29 Jul 2021

Gilead Sciences, Inc. announced a pooled analysis of a 48-week open-label extension of two Phase III studies (Study 1489 and Study 1490) shows 99% of participants who initiated… read more.

FDA approves Trodelvy, the first treatment for metastatic triple-negative breast cancer shown to improve progression-free survival and overall survival – Gilead Sciences

Written by | 18 Apr 2021

Gilead Sciences, Inc. announced that the FDA has granted full approval to Trodelvy (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)… read more.

EMA validates MAA for Trodelvy under accelerated review in triple-negative breast cancer – Gilead Sciences

Written by | 6 Apr 2021

Gilead Sciences announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for Trodelvy (sacituzumab govitecan-hziy) (SG) for the treatment of adult patients with… read more.

FDA approves Yescarta to treat relapsed or refractory follicular lymphoma after two lines of systemic therapy – Kite/Gilead Sciences

Written by | 13 Mar 2021

Kite, a Gilead Company announced that the FDA has granted accelerated approval to Yescarta (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma… read more.

Biktarvy shows high efficacy and durable viral suppression in treatment-naïve adults with HIV-1 in four-year data presented at CROI – Gilead Sciences

Written by | 11 Mar 2021

Gilead Sciences, Inc. announced new, long-term data from open-label extensions (OLE) of two Phase III studies (Study 1489 and Study 1490) of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir… read more.

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