The FDA granted accelerated approval to Zenbexus (iberdomide) in combination with daratumumab, hyaluronidase-fihj, and dexamethasone for adults with multiple myeloma previously treated with a proteasome...
The FDA approved an mRNA-based influenza vaccine mFLUSIVA for adults aged 50 years and older, with accelerated approval applying to adults aged 65 years and older.
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 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 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 has approved a supplemental indication for lumateperone to reduce relapse risk in adults with schizophrenia based on phase 3 randomized withdrawal data.
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 has granted full approval for the use of brexucabtagene autoleucel in adults with relapsed or refractory mantle cell lymphoma, based on confirmatory ZUMA-2 data.
The FDA has approved icotrokinra, an oral interleukin-23 receptor antagonist, for patients aged 12 years and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or...
