Over the past few months, the U.S. Food and Drug Administration approved new indications for existing and newly approved therapies. With the first two quarters of 2026 wrapped up, we’re taking a look back at the previous quarter to showcase the indications we feel were most noteworthy overall.

The following include new indications and expanded indications, arranged by specialty, for your browsing convenience. The bulk fall under oncology, with other focuses including cardiology, gastroenterology, and dermatology. 

Oncology

(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).

(Trodelvy) govitecan-hziy

  • 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.
  • 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

  • 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.

(Welireg + Keytruda QLEX) belzutifan + pembrolizumab and berahyaluronidase alfa-pmph

  • 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

  • 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.

(Cavhanza) nilotinib 

  • 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.

(Imfinzi) durvalumab

  • In combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).

(Decnupaz) pivekimab sunirine-pvzy 

  • For the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

(Datroway) datopotamab deruxtecan-dlnk

  • For the treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.

(Enhertu) fam-trastuzumab deruxtecan-nxki

  • For T-DXd for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab (with or without pertuzumab) and taxane-based treatment.
  • For T-DXd followed by a taxane, trastuzumab, and pertuzumab (THP), for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test.

(Tecentriq) atezolizumab

  • As an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) after cystectomy, as identified by Natera’s Signatera™ CDx personalized MRD assay.

(Tecentriq Hybreza) atezolizumab and hyaluronidase-tqjs

  • As an adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who have circulating tumor DNA molecular residual disease (ctDNA MRD) after cystectomy, as identified by Natera’s Signatera™ CDx personalized MRD assay.

(Inqovi) decitabine and cedazuridine 

  • Plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia (AML) who are 75 years or older or who are ineligible for intensive induction chemotherapy.

(Beqalzi) sonrotoclax

  • For the treatment of certain adults with relapsed or refractory mantle cell lymphoma (MCL).

(Bizengri) zenocutuzumab-zbco

  • For adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

(Veppanu) vepdegestrant 

  • For adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
Cardiology

(Baxfendy) baxdrostat  

  • For the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled.

Rapiblyk (landiolol)

  • For use in pediatric patients (from birth to <18 years of age) with supraventricular tachycardia (SVT).
Dermatology

(Skyrizi) risankizumab-rzaa

  • 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.

(Dupixent) dupilumab

  • Indication expanded to include children aged 2-11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite treatment with histamine 1 antihistamines (H1AH).
Gastroenterology

(Tryngolza) olezarsen

  • With diet, to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia.

(Linzess) linaclotide

  • In pediatric patients 2 years of age and older with functional constipation (FC).