FDA & EMA Related News

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

FDA Approves Libtayo as First Adjuvant Immunotherapy for High-Risk CS Cell Carcinoma

FDA Approves Tecentriq–Zepzelca Combo as FL Maintenance Therapy for ES-SC Lung Cancer

DESTINY-Breast05: Enhertu Outperforms T-DM1 in High-Risk HER2+ Early Breast Cancer

FDA Approves Imlunestrant for ESR1-Mutated Metastatic Breast Cancer

EMA’s CHMP Backs Subcutaneous Pembrolizumab in Head and Neck Cancer

FDA Grants Breakthrough Status to Izalontamab Brengitecan for EGF+ Lung Cancer

The First FDA-Cleared Blood Test for Alzheimer’s Diagnosis Now Available on the Market

FDA Grants Accelerated Approval to Semaglutide for MASH with Liver Fibrosis

FDA Approves Papzimeos, First Immunotherapy for Recurrent Respiratory Papillomatosis

FDA Grants Fast Track Designation to Birelentinib for Relapsed/Refractory CLL and SLL

Zongertinib Gains FDA Accelerated Approval for HER2+ NSCLC with 75% ORR

FDA Approves Modeyso as First-Ever Therapy for Pediatric Brain Tumor, H3 K27M+ Glioma

FDA Fast-Tracks Breyanzi as First CAR T Cell Therapy for Marginal Zone Lymphoma

Novel Viral Immunotherapy SuperNova Gains FDA Fast Track Designation for Sarcoma