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.
On May 1, the FDA approved vepdegestrant (Veppanu), a heterobifunctional protein degrader, for adults with estrogen receptor–positive, human epidermal growth factor receptor 2–negative, ESR1-mutated...
March 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 the second over-the-counter nasal spray with the goal of increasing access to products that can rapidly reverse the effects of opioid overdose.
The FDA approval expands 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...