FDA Alerts

FDA Approval
FDA Approval
04/15/2026
Anthony Calabro, MA
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.
04/15/2026
FDA Alert
FDA Alert
04/13/2026
Anthony Calabro, MA
On March 25, the FDA has approved relacorilant (Lifyorli), in combination with nab-paclitaxel for adults with platinum-resistant ovarian and related gynecologic cancers who have received prior systemic...
04/13/2026
FDA Approval
FDA Approval
04/02/2026
Anthony Calabro, MA
The FDA approved oral GLP-1 orforglipron (Foundayo) for weight management without food or water restrictions.
04/02/2026
FDA Approval
FDA Approval
03/27/2026
Anthony Calabro, MA
The FDA has approved insulin icodec-abae as the first once-weekly basal insulin option for glycemic control in adults with type 2 diabetes.
03/27/2026
FDA ALERT
FDA ALERT
03/26/2026
Ashton L. Stahl
The FDA has approved Avlayah (tividenofusp alfa-eknm) for certain pediatric patients with Hunter syndrome, marking the first approval targeting the disease's neurologic complications and offering clinicians...
03/26/2026
FDA Alert
FDA Alert
03/24/2026
Ashton L. Stahl
The FDA has approved Opdivo (nivolumab) in combination with doxorubicin, vinblastine, and dacarbazine for adults and pediatric patients aged 12 years and older with previously untreated stage III or IV...
03/24/2026
FDA Approval
FDA Approval
03/19/2026
Anthony Calabro, MA
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...
03/19/2026
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
03/03/2026
Anthony Calabro, MA
On March 3, 2026, the FDA approved the first generic of Flovent HFA (fluticasone propionate) inhalation aerosol, 44 mcg per actuation, for the maintenance treatment of asthma as prophylactic therapy in...
03/03/2026
FDA Alert
FDA Alert
02/25/2026
Kate Young
The FDA has approved dupilumab (Dupixent) for the treatment of allergic fungal rhinosinusitis, a rare form of chronic sinus inflammation driven by hypersensitivity to fungal organisms in the sinuses, in...
02/25/2026