The FDA approved tebipenem pivoxil (Utebzi) for adults with complicated urinary tract infections, including pyelonephritis, who have limited or no alternative oral treatment options.
June 2026 included several FDA drug and biologic approvals across a range of therapeutic areas. This timeline highlights the key alerts our publication covered throughout the month, giving readers a quick,...
The FDA approved sacituzumab govitecan-hziy (Trodelvy) as monotherapy, and with pembrolizumab-based therapy, for select adults with previously untreated unresectable locally advanced or metastatic...
The FDA approved expanded adjuvant therapy options for adults with renal cell carcinoma with a clear cell component who are at intermediate-high or high risk of recurrence after nephrectomy, with or without...
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 cefepime and zidebactam (Zaynich, Wockhardt), a novel intravenous antibiotic, for adults with complicated urinary tract infections, including pyelonephritis, caused by susceptible...
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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