FDA Approval
FDA Approval
07/07/2026
Anthony Calabro, MA
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.
07/07/2026
FDA Approval
FDA Approval
06/30/2026
Anthony Calabro, MA
The FDA approved tebipenem pivoxil (Utebzi) for adults with complicated urinary tract infections, including pyelonephritis, who have limited or no alternative oral treatment options.
06/30/2026
FDA Approval
FDA Approval
06/26/2026
Anthony Calabro, MA
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...
06/26/2026
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
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
03/06/2026
Kate Young
Based on findings from the phase 3 MajesTEC-3 trial, the FDA announced the approval of teclistamab (Tecvayli) plus daratumumab hyaluronidase-fihj for adults with relapsed or refractory multiple myeloma who...
03/06/2026
FDA Alert
FDA Alert
01/31/2025
Kate Young
The FDA has approved suzetrigine 50 milligram oral tablets for moderate to severe acute pain in adults. The drug acts on the peripheral nervous system before pain signals can reach the brain, eliminating...
01/31/2025
FDA Alert
FDA Alert
09/30/2024
Miranda Manier, BA
Two randomized, double-blind studies demonstrated that a new antipsychotic treatment for adult patients with schizophrenia may lead to a meaningful reduction in symptoms.
09/30/2024
FDA Alert
FDA Alert
03/04/2024
Anthony Calabro, MA
The FDA approved irinotecan liposome with oxaliplatin, fluorouracil, and leucovorin as a first-line regimen for the management of patients with metastatic pancreatic adenocarcinoma.
03/04/2024