FDA & EMA Related News
FDA Approves Darolutamide Plus ADT for mCS Prostate Cancer
FDA & EMA | 3 June 2025
EU Commission Approves Opdivo Regimen for High-Risk Resectable NSCLC
FDA & EMA | 16 May 2025
FDA Approves First Blood Test for Alzheimer’s, Marking a Historic Shift in Early Detection
Neurology | 16 May 2025
FDA Approves Emrelis as the First Targeted ADC for High c-Met Expressing Lung Cancer
FDA & EMA | 15 May 2025
Avutometinib Earn Accelerated FDA Approval for Ovarian Cancer
FDA & EMA | 9 May 2025
FDA Announces AI Strategy with First AI-Assisted Scientific Pilot for Drug Review
FDA & EMA | 8 May 2025
Adcentrx’s Nectin-4 ADC, ADRX-0706, Earns FDA Fast Track for Cervical Cancer
FDA & EMA | 7 May 2025
First AI-Driven Diagnostic Tool Wins FDA Breakthrough Designation for Lung Cancer
FDA & EMA | 30 April 2025
FDA Approves Tislelizumab Plus Chemotherapy for PD-L1+ Metastatic Esophageal Cancer
FDA & EMA | 4 March 2025
CHMP Recommends Durvalumab Combination for EU Approval in Resectable NSCLC
Enhertu Gains EMA’s CHMP Support for HER2-Low Metastatic Breast Cancer Treatment
FDA & EMA | 28 February 2025
KEYTRUDA Receives Priority FDA Review for Perioperative Use in ES Head and Neck Cancer
FDA & EMA | 26 February 2025
Odronextamab Gains FDA Review for Hard-to-Treat R/R Follicular Lymphoma
FDA Approves Innovative ADC Datroway for Metastatic HR+, HER2- Breast Cancer
FDA & EMA | 17 January 2025
FDA Approves Sotorasib and Panitumumab Combo for KRAS G12C+ Colorectal Cancer
FDA Approves 225Ac-SSO110 Radiopharmaceutical Trial for Small Cell Lung Cancer
FDA & EMA | 14 January 2025
FDA Grants Priority Review to Datopotamab Deruxtecan for EGFR+ Lung Cancer
First-Ever Obstructive Sleep Apnea Drug, Zepbound, Approved by FDA for Obesity
FDA & EMA | 21 December 2024
FDA Approves BRAFTOVI Combo as First-Line Treatment for Colorectal Cancer
FDA & EMA | 20 December 2024
FDA Grants Breakthrough Status to Datopotamab Deruxtecan for EGFR+ Lung Cancer
FDA & EMA | 10 December 2024
Promising Sac-TMT Receives FDA Breakthrough Therapy Designation for Lung Cancer
FDA & EMA | 7 December 2024
Durvalumab Granted FDA Priority Review for Muscle-Invasive Bladder Cancer Patients
FDA Approves Durvalumab as the First and Only Immunotherapy for LSSC Lung Cancer
FDA & EMA | 5 December 2024
FDA Grants Accelerated Approval to Bizengri for NRG1+ Pancreatic Cancer and NSCLC
The FDA Approves IMKELDI, the First Oral Liquid Form of Imatinib, for Leukemia
FDA & EMA | 27 November 2024
FDA Approves First Targeted Therapy for IDH-Mutant Glioma with Companion Diagnostic
Biotech | 21 October 2024
FDA Approves VYLOY™ as a New Targeted Therapy for Advanced Gastric and GEJ Cancer
FDA & EMA | 19 October 2024
AI-Powered Cancer Drug LP-184 Receives FDA Fast-Track Designation for Glioblastoma
FDA & EMA | 17 October 2024
FDA Approves TruSight Cancer Test for Matching Patients with Targeted Therapies
FDA & EMA | 2 September 2024
Nipocalimab Submitted to FDA for Treatment of Generalized Myasthenia Gravis
FDA & EMA | 30 August 2024
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