FDA & EMA Related News
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
FDA Approves Grifols' Yimmugo® for Primary Immunodeficiency, Marking a Milestone
FDA & EMA | 18 June 2024
Spinogenix's Daily Pill SPG302 Receives FDA IND Nod for ALS Treatment
FDA & EMA | 29 May 2024
New Treatment for AA Hepatitis: Larsucosterol Earns FDA Breakthrough Designation
FDA & EMA | 24 May 2024
FDA Approves IMDELLTRA for Lung Cancer After a 40% Response Rate
FDA & EMA | 17 May 2024
A New Horizon in Oncology: FDA Approves the First-Ever mRNA Cancer Vaccine
FDA & EMA | 10 May 2024
FDA Grants Full Approval for Tivdak® to Treat Recurrent or Metastatic Cervical Cancer
FDA & EMA | 1 May 2024
GenFleet Receives FDA Approval for P3 Trial of GFH925 in Colorectal Cancer Treatment
FDA & EMA | 29 April 2024
Transformative One-Time Gene Therapy: FDA Approves Pfizer's BEQVEZ, for Hemophilia B
FDA & EMA | 26 April 2024
FDA Approves Lutathera as First Treatment for Pediatric Neuroendocrine Tumors
FDA & EMA | 24 April 2024
FDA Approves New Imaging System to Enhance Tumor Detection in Cancer Surgery
FDA & EMA | 21 April 2024
Roche's Blood Test for Alzheimer's Earns FDA Breakthrough Device Designation
FDA & EMA | 18 April 2024
LSTA1 (Certepetide) Wins FDA Orphan Drug Status for Osteosarcoma Treatment
FDA & EMA | 15 April 2024
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