FDA Approvals

Based on results from the phase 3 SERENA-6 trial, the FDA granted accelerated approval to camizestrant plus a CDK4/6 inhibitor for HR-positive, HER2-negative advanced breast cancer following detection of an ESR1 mutation during ongoing...

The FDA has approved rusfertide for the treatment of erythrocytosis in adult patients with polycythemia vera after results from the phase 3 VERIFY trial showed showed improved hematocrit control, reduced phlebotomy requirements, and improved...

Based on results from the SURPASS ET trial, the FDA has approved ropeginterferon alfa-2b for adult patients with essential thrombocythemia regardless of genotype or disease status, marking the first new FDA-approved treatment for the disease...

The FDA approved daraxonrasib for adults with metastatic pancreatic adenocarcinoma who have received at least 1 prior systemic therapy or are not candidates for multiagent systemic therapy after phase 3 RASolute 302 data showed significant...

On August 25, 2026, the FDA approved zanidatamab plus chemotherapy, with or without tislelizumab, as a new first-line treatment for HER2-positive advanced gastroesophageal adenocarcinoma based on improved outcomes in the phase 3...

The FDA granted accelerated approval to iberdomide plus daratumumab and hyaluronidase and dexamethasone after the regimen nearly doubled the MRD-negative complete response rate compared with daratumumab and hyaluronidase plus bortezomib and...

The FDA has granted accelerated approval to vusolimogene oderparepvec plus nivolumab for patients with unresectable advanced cutaneous melanoma that has progressed following PD-1-blockade, based on durable responses observed in the phase 2...

The FDA has approved a rituximab biosimilar referencing Rituxan for multiple hematologic malignancies and autoimmune diseases. Approval was supported by a comprehensive biosimilar development program demonstrating high similarity and no...

The FDA has approved lutetium Lu 177 vipivotide tetraxetan in combination with androgen receptor pathway inhibitor therapy for patients with PSMA-positive metastatic hormone-sensitive prostate cancer. The approval was based on results from...

The FDA approved zidesamtinib for adults with previously treated locally advanced or metastatic ROS1-positive non-small cell lung cancer based on findings from the phase 1/2 ARROS-1 trial demonstrating durable responses, including in patients...