Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets), expanding its indication to include treatment of people with HIV (PWH) who have an antiretroviral treatment (ART) history but are not virologically suppressed, provided they have no known or suspected resistance to the integrase strand inhibitor (INSTI) class, emtricitabine, or tenofovir.
The U.S. FDA has approved KERENDIA® (finerenone), a non-steroidal mineralocorticoid receptor antagonist (nsMRA), for treating adults with heart failure (HF) and left ventricular ejection fraction (LVEF) ≥40%. This approval follows a Priority Review and is based on findings from the Phase III FINEARTS-HF trial. The new indication allows KERENDIA to be used for reducing cardiovascular (CV) death, hospitalization for heart failure, and urgent heart failure visits in patients with mildly reduced (HFmrEF) or preserved ejection fraction (HFpEF).
The U.S. Food and Drug Administration has approved Yeztugo (lenacapavir), a powerful new HIV-prevention drug developed by Gilead Sciences. Given via injection just twice a year, Yeztugo has shown remarkable success in clinical trials, virtually eliminating HIV transmission among recipients. It significantly outperformed existing daily oral PrEP drugs like Truvada, cutting infection rates by 89% among gay and bisexual men and transgender individuals. In a separate trial among cisgender women in sub-Saharan Africa, none of the participants who received Yeztugo contracted HIV.
On June 12, 2025, the FDA approved pembrolizumab (Keytruda) as a new treatment option for adults with resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) that shows PD-L1 expression with a combined positive score (CPS) of 1 or higher. This approval introduces a new approach to treating head and neck cancer that begins before surgery and continues afterward.
The research investigated the association of the Neutrophil Percentage-to-Albumin Ratio (NPAR) with mortality risk in diabetes or prediabetes patients. NPAR is a metric that reflects both inflammation, as presented in neutrophils, and nutrition, as presented in albumin. The researchers had 6,080 American adults with diabetes or prediabetes data, obtained between 2001 and 2018, via the National Health and Nutrition Examination Survey (NHANES). The population was followed up for a total of 53,217 person-years over which 1,378 deaths occurred, 476 from cardiovascular disease.
The FDA has provided traditional approval to pembrolizumab (Keytruda) plus trastuzumab, fluoropyrimidine-, and platinum-based chemotherapy for the initiation of treatment in adult patients with HER2-positive gastric or GEJ adenocarcinoma with PD-L1 expression (CPS ≥ 1). It was previously approved in May 2021, under accelerated approval, on the basis of interim results from the KEYNOTE-811 trial.
