The approval was supported by SCORPIO-PEP, a global, double-blind, randomized, placebo-controlled phase 3 study evaluating the safety and efficacy of ensitrelvir as post-exposure prophylaxis for COVID-19. The study included 2,387 participants aged 12 years and older with a negative local screening test for SARS-CoV-2 infection and no symptoms at enrollment who had been exposed to a household member with symptomatic COVID-19. The primary analysis included 2,041 household contacts with a central laboratory-confirmed negative SARS-CoV-2 test at baseline.
June 1: Ensitrelvir (Xocova)
On June 1, 2026, the FDA approved ensitrelvir (Xocova, Shionogi), an oral antiviral, for post-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older following contact with an individual who has COVID-19. Ensitrelvir is approved in the United States and Japan.
June 1: Cefepime and Zidebactam (Zaynich)
On June 1, 2026, Wockhardt Ltd announced that the FDA approved cefepime and zidebactam (Zaynich, Wockhardt), a novel intravenous antibiotic, for the treatment of adults with complicated urinary tract infections, including pyelonephritis, caused by susceptible Gram-negative pathogens.
The approval was based in part on ENHANCE-1, a phase 3 randomized, double-blind, multicenter study evaluating the efficacy, safety, and tolerability of cefepime and zidebactam compared with meropenem in 530 hospitalized adults with complicated urinary tract infection or acute pyelonephritis across 64 sites in the United States, Europe, Latin America, China, and India.
June 8: Marstacimab-hncq (Hympavzi)
On June 8, 2026, the FDA approved an expanded indication for marstacimab-hncq (Hympavzi; Pfizer Inc) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients aged 6 years and older with hemophilia A, with or without factor VIII inhibitors, or hemophilia B, with or without factor IX inhibitors.
The expanded indication includes patients aged 12 years and older with inhibitors and pediatric patients aged 6 to 11 years, with or without inhibitors. The approval in adults and adolescents aged 12 years and older with hemophilia A or B with inhibitors was supported by results from the global phase 3, open-label, multicenter BASIS trial.
June 12: Belzutifan (Welireg) Plus Pembrolizumab (Keytruda)
On June 12, the FDA approved belzutifan (Welireg, Merck & Co., Inc) in combination with pembrolizumab (Keytruda, Merck & Co., Inc) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc) for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy and resection of metastatic lesions.
The approval was supported by LITESPARK-022, a multicenter, double-blind, randomized trial enrolling 1841 patients with prior nephrectomy for clear cell renal cell carcinoma who were at intermediate-high or high risk of recurrence, or who had resected metastases with no evidence of disease.
June 17: Tebipenem Pivoxil (Utebzi)
On June 17, the FDA approved tebipenem pivoxil (Utebzi; GlaxoSmithKline, plc) tablets for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, caused by susceptible microorganisms in adults with limited or no alternative oral treatment options. Tebipenem pivoxil is the first oral carbapenem therapy approved for this indication.
The FDA noted that patients with allergic reactions to tebipenem pivoxil or other beta-lactam antibacterials should not take the medication. It should also not be used in patients with primary or secondary carnitine deficiency or inborn errors of metabolism that may result in clinically significant carnitine deficiency.
June 24: Sacituzumab Govitecan (Trodelvy)
On June 24, the FDA approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc) for 2 first-line indications in adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). Sacituzumab govitecan-hziy was approved as monotherapy for adults who are not candidates for PD-1 or PD-L1 inhibitor-based therapy and, in combination with pembrolizumab or with pembrolizumab and berahyaluronidase alfa-pmph, for adults whose tumors express PD-L1, defined as CPS ≥10 by an FDA-authorized test.
The monotherapy indication was supported by ASCENT-03, a multicenter, open-label, randomized trial involving 558 patients who had not previously received systemic therapy for advanced disease and were not candidates for PD-1 or PD-L1 inhibitor therapy. The median progression-free survival rate was 9.7 months with sacituzumab govitecan-hziy vs 6.9 months with treatment of the physician’s choice (hazard ratio, 0.62; 95% CI, 0.50-0.77; P < .0001).