FDA Approvals, News & Updates

Sunvozertinib (Zegfrovy) has been greenlit by the FDA for adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. Read More ›

On August 6, 2025, officials with the FDA granted accelerated approval to dordaviprone (Modeyso), a protease activator, for adult and pediatric patients aged ≥1 year with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. Read More ›

FDA officials have granted accelerated approval to zongertinib (Hernexeos), a kinase inhibitor, for adults with unresectable or metastatic nonsquamous non–small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD)-activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy. Read More ›

Officials with the FDA recently approved belzutifan (Welireg; Merck) for people aged ≥12 years with locally advanced unresectable or metastatic pheochromocytoma or paraganglioma (PPGL), making it the first FDA approval of an oral therapy for PPGL. 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 ›

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 ›

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 ›