On March 26, 2026, the US Food and Drug Administration approved Awiqli (insulin icodec-abae) injection 700 units/mL as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

On March 25, the FDA approved Avlayah (tividenofusp alfa-eknm) to treat the neurologic manifestations of Hunter syndrome, also known as mucopolysaccharidosis type II, in presymptomatic or symptomatic pediatric patients weighing at least 5 kg who have not yet developed advanced neurologic impairment. According to the agency, tividenofusp alfa-eknm is administered as an intravenous infusion and is the first approved product to address neurologic complications of Hunter syndrome.

On March 25, the FDA approved relacorilant (Lifyorli), a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Eligible patients must have received 1 to 3 prior systemic treatment regimens, including at least 1 that included bevacizumab.

The approval was based on findings from ROSELLA (NCT05257408), a multicenter, open-label trial enrolling 381 patients with platinum-resistant disease. Patients were randomized (1:1) to receive relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The major efficacy outcome measures were progression-free survival (PFS) and overall survival (OS). Median PFS was 6.5 months (95% CI, 5.6–7.4) with the combination vs 5.5 months (95% CI, 3.9–5.9) with nab-paclitaxel alone (hazard ratio, 0.70; P = .0076). Median OS was 16 months (95% CI, 13–18.3) vs 11.9 months (95% CI, 10–13.8), respectively (hazard ratio, 0.65; P = .0004).

On March 20, 2026, the FDA approved Opdivo (nivolumab) with doxorubicin, vinblastine, and dacarbazine (AVD) for adult and pediatric patients aged 12 years and older with previously untreated stage III or IV classical Hodgkin lymphoma. The agency also granted traditional approval to nivolumab for certain adults with relapsed or refractory classical Hodgkin lymphoma after prior autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or after 3 or more lines of systemic therapy that includes autologous HSCT.  

On March 18, 2026, the FDA approved Icotyde (icotrokinra), an oral peptide that targets the interleukin-23 (IL-23) receptor, for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 years and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy.

Approval was supported by data from 4 phase 3 studies within the ICONIC clinical development program, which included approximately 2,500 patients. These randomized trials evaluated icotrokinra in adults and adolescents, including patients with disease involving high-impact sites such as the scalp and genital areas, and included head-to-head studies versus an active comparator. In these studies, approximately 70% of patients treated with icotrokinra achieved Investigator’s Global Assessment (IGA) scores of 0 or 1, and 55% achieved a Psoriasis Area and Severity Index (PASI) 90 response at week 16.

The FDA approved teclistamab (Tecvayli) plus daratumumab hyaluronidase-fihj for adults with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent following recent safety and efficacy data from the MajesTEC-3 trial. This approval also converted the 2022 accelerated approval for teclistamab to a traditional approval as a monotherapy in adult patients who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

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 adults and children aged 4 years and older. Fluticasone propionate is an inhaled corticosteroid designed to reduce airway inflammation and prevent asthma symptoms, including wheezing and shortness of breath.

According to the FDA, the approval represents the first generic metered-dose inhaler form of fluticasone propionate inhalation aerosol.