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

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 of relapsed or refractory (R/R) non-Hodgkin lymphoma, which were presented at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition. This included ZUMA-1 (Abstract #4864) showing that patients with refractory […]

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

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 people with mild, moderate and severe hepatic impairment. This approval further supports the safety profile of Veklury as the first and only approved antiviral COVID-19 treatment that can be used across all […]

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

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 (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting. The approval by the European Commission follows the positive opinion of the […]

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

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 findings underscore the role of lenacapavir, the first long-acting injectable HIV treatment medication administered twice-yearly, as a person-centric therapy option and its transformative potential impact on the future of coordinated HIV clinical […]

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

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 at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy. The approval of this supplemental New Drug Application (sNDA) expands the indication for Biktarvy […]

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

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 phase III open-label DisCoVeRy trial included patients admitted to hospital with laboratory-confirmed SARS-CoV-2 and if they had evidence of pneumonia or required oxygen. Participants were randomized to standard of care alone or […]

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

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

Copyright © ICR (UK) Limited t/a International Medical Information (IMI). Registered in the UK Company no. 05894351 medicalupdateonline.com is brought to you by International Medical Information. For more details, visit http://www.medicalimi.com Disclaimer: All information on this site has been collated by healthcare professionals from around the globe. Where every possible step has been taken to ensure its accuracy, MedicalUpdateOnline cannot […]