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 has approved veligrotug-vvze (Lumvoa) for the treatment of thyroid eye disease regardless of disease activity or duration, based on the pivotal phase 3 THRIVE and THRIVE-2 clinical trials.
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 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...
May 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,...
