The FDA approved ensitrelvir (Xocova) for post-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older following contact with an individual with COVID-19.
The FDA approved tebipenem pivoxil (Utebzi) for adults with complicated urinary tract infections, including pyelonephritis, who have limited or no alternative oral treatment options.
The FDA approved cefepime and zidebactam (Zaynich, Wockhardt), a novel intravenous antibiotic, for adults with complicated urinary tract infections, including pyelonephritis, caused by susceptible...
The FDA approval expands the use of marstacimab-hncq (Hympavzi; Pfizer Inc.) for routine prophylaxis to prevent or reduce bleeding episodes in additional pediatric and inhibitor-positive hemophilia A and B...
The FDA approved Baxfendy as an adjunctive treatment to lower blood pressure in adults with hypertension not adequately controlled on other antihypertensive medications.
On May 22, 2026, the FDA approved datopotamab deruxtecan-dlnk for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy, based on...
The FDA approved Enhertu for neoadjuvant treatment of adults with HER2-positive stage II or III breast cancer and adjuvant treatment of patients with residual invasive disease after neoadjuvant therapy.
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The FDA approved oral decitabine and cedazuridine (Inqovi) tablets with venetoclax for adults with newly diagnosed acute myeloid leukemia who are aged 75 years or older or have comorbidities that preclude...
The FDA approved Bizengri for adults with advanced, unresectable, or metastatic NRG1 fusion-positive cholangiocarcinoma after prior systemic therapy, providing a new targeted option for an ultra-rare and...
