FDA & EMA Related News
FDA Approves Sotorasib and Panitumumab Combo for KRAS G12C+ Colorectal Cancer
FDA & EMA | 17 January 2025
FDA Approves Innovative ADC Datroway for Metastatic HR+, HER2- Breast Cancer
FDA Grants Priority Review to Datopotamab Deruxtecan for EGFR+ Lung Cancer
FDA & EMA | 14 January 2025
FDA Approves 225Ac-SSO110 Radiopharmaceutical Trial for Small Cell 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
Novel Cancer Drug PT217 Wins FDA Orphan Drug Status for Neuroendocrine Carcinoma
FDA & EMA | 20 August 2024
Mixed-Reality System, HipInsight, Receives FDA Approval for Hip Surgery
FDA & EMA | 13 August 2024
FDA Approves Neffy: First Nasal Spray for Emergency Allergic Reactions
FDA & EMA | 10 August 2024
Iptacopan, the First CI, Wins FDA Accelerated Approval for IgA Nephropathy
FDA & EMA | 8 August 2024
FDA Approves Vorasidenib as First Targeted Therapy for G2 IDH-Mutant Glioma
FDA & EMA | 7 August 2024
FDA Approves Expanded Use of Dostarlimab for Treatment of Endometrial Cancers
FDA & EMA | 2 August 2024
FDA Approves Johnson's Daratumumab Plus VRd for Newly Diagnosed Multiple Myeloma
FDA & EMA | 30 July 2024
FDA Approves Expanded Use of Xembify for Immunodeficiency Treatment
FDA & EMA | 29 July 2024
Anixa's CAR-T Therapy for Ovarian Cancer Earns FDA IND Approval
FDA & EMA | 25 July 2024
FDA Clears ZW191 for Clinical Trials: Novel Drug Targets NSCLC and Ovarian Cancer
FDA & EMA | 24 July 2024
FDA Approves Kisunla, a Novel Alzheimer's Therapy Targeting Amyloid Plaques
FDA & EMA | 3 July 2024
FDA Grants Fast-Track Designation to SYNC-T SV-102 for Prostate Cancer
FDA & EMA | 2 July 2024
FDA Approves Trials for ZW171: A Novel Bispecific Antibody for Hard-to-Treat Cancers
FDA & EMA | 21 June 2024
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