USFDA

In a major advancement in the fight against antibiotic-resistant infections, the U.S. Food and Drug Administration (FDA) has approved Utebzi (tebipenem pivoxil hydrobromide), the first oral carbapenem antibiotic for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis. The approval provides patients and healthcare providers with a long-awaited oral alternative to intravenous carbapenem therapy.

In a significant step toward improving access to influenza treatment, the U.S. Food and Drug Administration (FDA) has approved the first generic version of baloxavir marboxil tablets, a single-dose antiviral medicine used for the treatment and prevention of influenza. The approval comes just before the start of the 2026-27 flu season and is expected to provide patients with a more affordable treatment option.

The U.S. Food and Drug Administration (FDA) has approved Xocova (ensitrelvir), developed by Japanese pharmaceutical company Shionogi & Co., for the prevention of COVID-19 following exposure to an infected individual. The approval makes Xocova the first and only oral antiviral therapy authorized in the United States for post-exposure prophylaxis of COVID-19.

AstraZeneca and Daiichi Sankyo have announced that the U.S. Food and Drug Administration (FDA) has approved DATROWAY (datopotamab deruxtecan-dlnk) for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval makes DATROWAY the first TROP2-directed antibody-drug conjugate (ADC) approved in the United States for first-line treatment in this patient population.

In a major breakthrough for liver disease treatment, Gilead Sciences has received accelerated approval from the U.S. FDA for Hepcludex (bulevirtide-gmod), making it the first and only approved therapy for chronic Hepatitis Delta Virus (HDV) infection in the United States.

The U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarring) or with compensated cirrhosis. Bulevirtide is the first FDA-approved treatment for chronic HDV infection, a serious and life-threatening condition that can cause rapid development of liver fibrosis (scarring), liver cancer, liver failure, and even death.

Genentech has announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq and Tecentriq Hybreza for the adjuvant treatment of adults with muscle-invasive bladder cancer (MIBC) who show circulating tumor DNA molecular residual disease (ctDNA MRD) after bladder removal surgery. The approval marks the first FDA-cleared ctDNA-guided therapy approach for this aggressive cancer type.

The U.S. Food and Drug Administration (FDA) has announced a new initiative aimed at accelerating the repurposing of already approved medicines to treat diseases with significant unmet medical needs, including rare disorders, neurodegenerative diseases, metabolic conditions, and substance use disorders.