A consolidated list of all the FDA approved medications during the month of June 2026.
- Tregzi (allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq)
- For improving chronic graft-versus-host disease (GVHD)-free survival in adult patients with blood cancers undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Skyrizi (risankizumab-rzaa) Expanded Indication
- For the treatment of children six years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis.
- Lumvoa (veligrotug-vvze)
- For the treatment of thyroid eye disease (TED)
- Trodelvy (govitecan-hziy) New Indication
- In combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the first-line treatment of adults with unresectable locally advanced
- or metastatic TNBC whose tumors express PD-L1 (CPS ≥ 10) as determined by an FDA-authorized test.
- Trodelvy (govitecan-hziy) New Indication
- For the first-line treatment of adults with unresectable locally advanced or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitor-based therapy.
- Ibrance (palbociclib) New Indication
- In combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.
- Tryngolza (olezarsen) New Indication
- With diet, to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia.
- Ambelvist (gadoquatrane)
- For contrast-enhanced magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system (CNS) and non-CNS body regions in adult and pediatric patients, including term neonates.
- Utebzi (tebipenem pivoxil)
- For the treatment of complicated urinary tract infections (cUTI), including pyelonephritis.
- Tzield (teplizumab-mzwv) New Indication
- To delay the decline in endogenous (own) insulin production in children aged eight to 17 years recently diagnosed with stage 3 type 1 diabetes.
- Welireg + Keytruda QLEX (belzutifan + pembrolizumab and berahyaluronidase alfa-pmph) New Indication
- For the adjuvant treatment of adult patients with clear cell renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.
- Welireg + Keytruda (belzutifan + pembrolizumab) New Indication
- For the adjuvant treatment of adult patients with clear cell renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.
- Truqap (capivasertib with abiraterone and prednisone) New Indication
- In combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer) that is PTEN-deficient as detected by an FDA-authorized test.
- Hympavzi (marstacimab-hncq) Expanded Indication
- To include the treatment of patients with hemophilia A or B 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors.
- Ranluspec (ranibizumab-hkdz) Biosimilar to Lucentis
- For the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.
- Cavhanza (nilotinib) New Formulation
- Newly diagnosed adults with Ph+ CML in chronic phase; and adults with chronic and accelerated phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib.
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