FDA Approvals

The FDA has approved imlunestrant for patients with ER-positive, HER2-negative advanced or metastatic breast cancer harboring ESR1 mutations.

The FDA has approved subcutaneous pembrolizumab plus berahylaruonidase alfa for patients with solid tumors eligible to receive intravenous pembrolizumab.

The FDA has accepted an NDA for relacorilant as a treatment for patients with platinum-resistant ovarian cancer.

The FDA has approved selumetinib granules and capsules for pediatric patients ≥ 1 year of age with neurofibromatosis type 1 who have symptomatic and inoperable plexiform neurofibromas.

On Tuesday, September 9, 2025, the FDA approved the use of a gemcitabine intravesical system, TAR-200, for the treatment of patients with Bacillus Calmette-Guérin–unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or...

Based on results from the Beamion LUNG-1 trial, the US FDA has approved zongertinib for previously treated patients with unresectable or metastatic non-squamous non-small cell lung cancer with HER2 tyrosine kinase domain activating mutations.

The FDA has granted accelerated approval for dordaviprone for the treatment of patients with diffuse midline glioma.

Based on interim results from the DOORwaY90 trial, the FDA has approved Y-90 resin microspheres for the treatment of patients with unresectable hepatocellular carcinoma.

On July 2, 2025, the FDA granted accelerated approval to sunvozertinib for the treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations.

The US FDA approved linvoseltamab-gcpt for the treatment of adults with relapsed/refractory multiple myeloma based on results from the LINKER-MM1 clinical trial.