FDA Approvals, News & Updates
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 ›
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 ›
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 ›