FDA Approval
FDA Approval
06/25/2026
Anthony Calabro, MA
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...
06/25/2026
FDA Approval
FDA Approval
06/23/2026
Anthony Calabro, MA
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.
06/23/2026
FDA Approval
FDA Approval
06/23/2026
The FDA approved tebipenem pivoxil (Utebzi) for adults with complicated urinary tract infections, including pyelonephritis, who have limited or no alternative oral treatment options.
06/23/2026
FDA Approval
FDA Approval
06/12/2026
Anthony Calabro, MA
The FDA approved cefepime and zidebactam (Zaynich, Wockhardt), a novel intravenous antibiotic, for adults with complicated urinary tract infections, including pyelonephritis, caused by susceptible...
06/12/2026
FDA Alert
FDA Alert
06/09/2026
Ashton L. Stahl
FDA approval gives physicians the first authorized treatment option for adults with chronic hepatitis delta virus infection.
06/09/2026
FDA Approval
FDA Approval
06/08/2026
Anthony Calabro, MA
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...
06/08/2026
FDA Approval
FDA Approval
05/25/2026
Anthony Calabro, MA
The FDA approved Baxfendy as an adjunctive treatment to lower blood pressure in adults with hypertension not adequately controlled on other antihypertensive medications.
05/25/2026
FDA Alert
FDA Alert
05/22/2026
Anthony Calabro, MA
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...
05/22/2026
FDA Alert
FDA Alert
05/21/2026
Anthony Calabro, MA
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. ...
05/21/2026
FDA Alert
FDA Alert
05/20/2026
Anthony Calabro, MA
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...
05/20/2026