FDA Approvals, News & Updates

Darolutamide (Nubeqa; Bayer Healthcare Pharmaceuticals) has been approved by the FDA for metastatic castration-sensitive prostate cancer (mCSPC), following an earlier approval to be used in combination with docetaxel for mCSPC. Read More ›

Both single-agent retifanlimab-dlwr (Zynyz; Incyte) and use with carboplatin and paclitaxel have been greenlit for the first-line treatment of adults with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal. Read More ›

On June 11, 2025, officials with the FDA approved taletrectinib (Ibtrozi; Nuvation Bio), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non–small cell lung cancer. Read More ›

Mitomycin intravesical solution (Zusduri; UroGen Pharma) may now be used to treat adult patients with recurrent intermediate-risk, low-grade, non-muscle invasive bladder cancer after an FDA approval in June. Read More ›

Pembrolizumab (Keytruda; Merck) has received an FDA nod for adults with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 combined positive score ≥1, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy with or without cisplatin after surgery, and then as a single agent. Read More ›

On June 18, 2025, the FDA approved tafasitamab-cxix (Monjuvi; Incyte) with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma. Read More ›

Officials with the FDA have approved nivolumab (Opdivo; Bristol Myers Squibb) with ipilimumab (Yervoy; Bristol Myers Squibb Company) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma, and other updates. Read More ›

The FDA has approved penpulimab-kcqx (Akeso Biopharma Co, Ltd) with cisplatin or carboplatin and gemcitabine for the first-line treatment of adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) and as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and at least 1 other previous line of therapy. Read More ›

Nivolumab (Opdivo; Bristol Myers Squibb) with ipilimumab (Yervoy; Bristol Myers Squibb) is now FDA approved for patients aged ≥12 years with unresectable or metastatic microsatellite instability-high or mismatch repair–deficient colorectal cancer. Read More ›

Officials with the FDA have approved tislelizumab-jsgr (Tevimbra; BeOne Medicines, Ltd, formerly known as BeiGene, Ltd), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express programmed death-ligand 1. Read More ›