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FDA Approvals

FDA Approval
FDA Approves Lirafugratinib for Previously Treated FGFR2-Altered Cholangiocarcinoma
09/23/2026
Emily Estrada
Based on results from the REFOCUS trial, the FDA has approved lirafugratinib for previously treated patients with unresectable or advanced FGFR2-altered cholangiocarcinoma, providing an additional targeted treatment option for patients with...
Based on results from the REFOCUS trial, the FDA has approved lirafugratinib for previously treated patients with unresectable or advanced FGFR2-altered cholangiocarcinoma, providing an additional targeted treatment option for patients with...
Based on results from the...
09/23/2026
Oncology
FDA Approval
FDA Approves Bravnetsa as Bioequivalent and Therapeutically Equivalent Lutetium Lu 177 Dotatate for SSTR-Positive GEP-NETs
09/23/2026
Stephanie Holland
The FDA approved Bravnetsa for adults with SSTR-positive gastroenteropancreatic neuroendocrine tumors, introducing a bioequivalent and therapeutically equivalent lutetium Lu 177 dotatate radioligand therapy through the abbreviated new drug...
The FDA approved Bravnetsa for adults with SSTR-positive gastroenteropancreatic neuroendocrine tumors, introducing a bioequivalent and therapeutically equivalent lutetium Lu 177 dotatate radioligand therapy through the abbreviated new drug...
The FDA approved Bravnetsa for...
09/23/2026
Radiopharmaceutical Education Institute

Recent News

FDA Approval
FDA Approves Lirafugratinib for Previously Treated FGFR2-Altered Cholangiocarcinoma
09/23/2026
Emily Estrada
Based on results from the REFOCUS trial, the FDA has approved lirafugratinib for previously treated patients with unresectable or advanced FGFR2-altered cholangiocarcinoma, providing an additional targeted treatment option for patients with...
Based on results from the REFOCUS trial, the FDA has approved lirafugratinib for previously treated patients with unresectable or advanced FGFR2-altered cholangiocarcinoma, providing an additional targeted treatment option for patients with...
Based on results from the...
09/23/2026
Oncology
FDA Approval
FDA Approves Bravnetsa as Bioequivalent and Therapeutically Equivalent Lutetium Lu 177 Dotatate for SSTR-Positive GEP-NETs
09/23/2026
Stephanie Holland
The FDA approved Bravnetsa for adults with SSTR-positive gastroenteropancreatic neuroendocrine tumors, introducing a bioequivalent and therapeutically equivalent lutetium Lu 177 dotatate radioligand therapy through the abbreviated new drug...
The FDA approved Bravnetsa for adults with SSTR-positive gastroenteropancreatic neuroendocrine tumors, introducing a bioequivalent and therapeutically equivalent lutetium Lu 177 dotatate radioligand therapy through the abbreviated new drug...
The FDA approved Bravnetsa for...
09/23/2026
Radiopharmaceutical Education Institute
News
FDA Grants Accelerated Approval to Iberdomide Combination for Relapsed or Refractory Multiple Myeloma
08/13/2026
Stephanie Holland
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 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 granted accelerated...
08/13/2026
Oncology
News
Perioperative Enfortumab Vedotin Plus Pembrolizumab Outperforms Cisplatin Plus Gemcitabine in Muscle-Invasive Bladder Cancer
08/12/2026
Stephanie Holland
Results from the phase 3 KEYNOTE-B15/EV-304 trial showed that perioperative enfortumab vedotin plus pembrolizumab improved survival and response compared with neoadjuvant cisplatin plus gemcitabine in cisplatin-eligible muscle-invasive...
Results from the phase 3 KEYNOTE-B15/EV-304 trial showed that perioperative enfortumab vedotin plus pembrolizumab improved survival and response compared with neoadjuvant cisplatin plus gemcitabine in cisplatin-eligible muscle-invasive...
Results from the phase 3...
08/12/2026
Oncology
News
BEGONIA Shows No Added Benefit With Capivasertib or Oleclumab Added to Durvalumab Plus Paclitaxel in Advanced Triple-Negative Breast Cancer
08/12/2026
Emily Estrada
Results from the phase 1b/2 BEGONIA trial showed clinical activity with first-line durvalumab plus paclitaxel in unresectable locally advanced or metastatic triple-negative breast cancer, while adding capivasertib or oleclumab provided no...
Results from the phase 1b/2 BEGONIA trial showed clinical activity with first-line durvalumab plus paclitaxel in unresectable locally advanced or metastatic triple-negative breast cancer, while adding capivasertib or oleclumab provided no...
Results from the phase 1b/2...
08/12/2026
Oncology
News
Subcutaneous Pertuzumab Plus Trastuzumab Shows Comparable 4-Year Outcomes to Intravenous Therapy in HER2-Positive Breast Cancer
08/12/2026
Emily Estrada
Long-term results from the phase 3 FeDeriCa trial showed that fixed-dose subcutaneous pertuzumab plus trastuzumab maintained efficacy and a comparable safety profile versus intravenous therapy in HER2-positive early breast cancer, supporting...
Long-term results from the phase 3 FeDeriCa trial showed that fixed-dose subcutaneous pertuzumab plus trastuzumab maintained efficacy and a comparable safety profile versus intravenous therapy in HER2-positive early breast cancer, supporting...
Long-term results from the phase...
08/12/2026
Oncology
News
Foundation AI Model Surpasses Early-Career Dermatologists but Falls Short of Experts in Skin Cancer Diagnosis
08/12/2026
Stephanie Holland
A multicenter diagnostic study found that a modern artificial intelligence (AI) foundation model outperformed physicians with fewer than 3 years of dermatology experience and matched midcareer clinicians in skin cancer diagnosis but remained...
A multicenter diagnostic study found that a modern artificial intelligence (AI) foundation model outperformed physicians with fewer than 3 years of dermatology experience and matched midcareer clinicians in skin cancer diagnosis but remained...
A multicenter diagnostic study...
08/12/2026
Oncology
News
Two Injection Sites Outperformed Single-Site Delivery for Melanoma Peptide Vaccine
08/12/2026
Stephanie Holland
Long-term results from a randomized phase 2 trial showed that administering a 12-peptide melanoma vaccine at 2 injection sites significantly improved recurrence-free survival in patients with resected high-risk melanoma, whereas adding GM-CSF...
Long-term results from a randomized phase 2 trial showed that administering a 12-peptide melanoma vaccine at 2 injection sites significantly improved recurrence-free survival in patients with resected high-risk melanoma, whereas adding GM-CSF...
Long-term results from a...
08/12/2026
Oncology
News
Sonrotoclax Monotherapy Demonstrates Meaningful Activity in Heavily Pretreated Mantle Cell Lymphoma
08/12/2026
Emily Estrada
Results from a phase 1/2 study showed that sonrotoclax monotherapy produced rapid and durable responses with a manageable safety profile in patients with relapsed or refractory mantle cell lymphoma previously treated with anti-CD20–based...
Results from a phase 1/2 study showed that sonrotoclax monotherapy produced rapid and durable responses with a manageable safety profile in patients with relapsed or refractory mantle cell lymphoma previously treated with anti-CD20–based...
Results from a phase 1/2 study...
08/12/2026
Oncology
News
Ociperlimab Plus Tislelizumab Fails to Improve Survival Over Pembrolizumab in PD-L1-High Advanced Non-Small Cell Lung Cancer
08/11/2026
Emily Estrada
Ociperlimab plus tislelizumab failed to improve overall survival compared with pembrolizumab as first-line treatment for patients with stage III/IV non-small cell lung cancer and PD-L1 expression of ≥50%, leading to the phase 3 AdvanTIG-302...
Ociperlimab plus tislelizumab failed to improve overall survival compared with pembrolizumab as first-line treatment for patients with stage III/IV non-small cell lung cancer and PD-L1 expression of ≥50%, leading to the phase 3 AdvanTIG-302...
Ociperlimab plus tislelizumab...
08/11/2026
Oncology

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