FDA & EMA Related News

FDA Approves Enhertu for Two New HER2-Positive Early Breast Cancer Indications

FDA Approves First All-Oral INQOVI Plus Venetoclax Regimen for Newly Diagnosed AML

FDA Approves Sonrotoclax as First BCL2 Inhibitor for R/R Mantle Cell Lymphoma

FDA Approves Bizengri as First Targeted Therapy for NRG1 Fusion+ Cholangiocarcinoma

FDA Grants RMAT Designation to RZ-001, a Novel RNA Therapy for Hepatocellular Carcinoma

FDA Grants Fast Track Designation to RPTR-1-201 for Advanced Triple- Breast Cancer

FDA Grants Fast Track Designation to Dubodencel for Advanced Cutaneous Melanoma

FDA Accepts IBTROZI sNDA After Durable Long-Term Benefit in Advanced ROS1+ Lung Cancer

FDA ODAC Backs Truqap Combination for PTEN-Deficient Metastatic Prostate Cancer

FDA Approves Vepdegestrant, First PROTAC Therapy for ESR1+ ER+/HER2- Breast Cancer

Zeta Navigation System Gains FDA Clearance for Brain Tumor Biopsy and Neurosurgery

AidaBREAST Gains FDA Breakthrough Status for Personalized Radiotherapy in Breast Cancer

FDA Grants Breakthrough Status to First Viral Liquid Biopsy in Hepatocellular Carcinoma

FDA Gives Priority Review to PADCEV Plus Pembrolizumab in MI Bladder Cancer

Zenocutuzumab Gains NCCN Support as FDA Review Advances in Cholangiocarcinoma

FDA Grants Priority Review to Ifinatamab Deruxtecan in Pretreated ES-SC Lung Cancer

Mocertatug Rezetecan Shows Strong Responses in Ovarian and Endometrial Cancers

Neladalkib Reaches FDA Review for TKI-Pretreated ALK+ Non-Small Cell Lung Cancer

FDA Grants Breakthrough Status to WU-CART-007 for T-Cell Leukemias and Lymphomas

FDA Approves Agilent’s PD-L1 Test to Guide KEYTRUDA Use in Esophageal and GEJ Carcinoma

FDA Approves Nivolumab-AVD as First Immunotherapy Combination for Hodgkin Lymphoma

FDA Approves First Subcutaneous Amivantamab Plus Lazertinib for EGFR+ Lung Cancer

FDA Approves T-DXd Plus Pertuzumab as a First-Line Standard in HER2+ Breast Cancer

FDA Approves AKEEGA for BRCA2+ Prostate Cancer as the First Precision Therapy

GSK’s ADC Risvutatug Rezetecan Earns FDA Orphan Drug Status for Small Cell Lung Cancer

FDA Approves Durvalumab as First Perioperative Immunotherapy for GEJ Cancers

FDA Approves Keytruda–Padcev Combo as First Perioperative Treatment for Bladder Cancer

Sevabertinib Wins FDA Approval with Strong Responses in HER2+ NSC Lung Cancer

FDA Approves Epcoritamab-bysp as the First Bispecific Antibody for Follicular Lymphoma

FDA Approves Ziftomenib as a New Targeted Option for NPM1+ Acute Myeloid Leukemia