Drug Approvals
Page 1 • 12 itemsTrack global drug approvals & regulatory decisions. Gain critical intelligence on new therapies, market access, and competitive landscapes for pharma BD.
Vanda Pharmaceuticals Launches NEREUS (Tradipitant) - First New Motion Sickness Drug in 40+ Years Now Available
Vanda Pharmaceuticals announces commercial availability of NEREUS (tradipitant), the first new prescription motion sickness treatment in over 40 years.
FDA Approves LANGLARA Interchangeable Biosimilar to Lantus Insulin - Lannett Company Receives Key Diabetes Drug Approval
FDA approves LANGLARA (insulin glargine-aldy) as interchangeable biosimilar to Lantus for diabetes treatment in adults and pediatric patients.
Vertex CASGEVY Gene Therapy Reaches 60,000+ Eligible Patients Across 10 Countries as Q1 2026 Results Show Global Expansion
Vertex's CASGEVY, the first approved CRISPR gene therapy, now serves 60,000+ eligible sickle cell disease and beta thalassemia patients across 10 countries.
FDA Approves Auvelity for MDD: Axsome Therapeutics Scores Win
The U.S. Food and Drug Administration (FDA) has approved Auvelity, a novel oral antidepressant developed by Axsome Therapeutics, for the treatment of Major Depressive Disorder (MDD) in adults. This approval represents a significant advancement in the mental health landscape.
Auvelity FDA Approval: New Hope for MDD Patients
The FDA has approved Auvelity, a groundbreaking oral antidepressant from Axsome Therapeutics, marking a significant advancement in treating major depressive disorder (MDD). This approval introduces a novel mechanism of action for patients seeking effective relief.
FDA Approves Auvelity for MDD: Axsome Therapeutics' New Antidepressant
The FDA has granted approval for Auvelity, a new oral antidepressant developed by Axsome Therapeutics, to treat major depressive disorder (MDD) in adults. This marks a significant advancement in mental health treatment, offering a novel mechanism of action and potentially rapid symptom relief.
Plozasiran TGA Approval in Australia for FCS Patients
Arrowhead Pharmaceuticals has announced the Therapeutic Goods Administration (TGA) approval of REDEMPLO® (plozasiran) in Australia for patients with Familial Chylomicronemia Syndrome (FCS). This landmark decision broadens global access to a crucial treatment for this rare genetic disorder.
HUTCHMED's Sovleplenib Receives Priority Review and Breakthrough Designation in China for Rare Blood Disorder
HUTCHMED announces NDA acceptance with priority review status for sovleplenib to treat warm antibody autoimmune hemolytic anemia in China.
European Commission Approves POHERDY, First Pertuzumab Biosimilar in Europe by Henlius and Organon
EC grants marketing authorization for POHERDY (pertuzumab), the first approved biosimilar to PERJETA in Europe, developed by Henlius Biotech and Organon.
Norgine Receives European Approval for XOLREMDI (Mavorixafor), First WHIM Syndrome Treatment in EU
Norgine's XOLREMDI becomes the first authorized treatment for WHIM syndrome in Europe, marking a breakthrough for ultra-rare immunodeficiency patients.
Norgine Receives European Commission Approval for XOLREMDI (Mavorixafor) as First WHIM Syndrome Treatment
Norgine's XOLREMDI becomes first authorized treatment for WHIM syndrome in Europe, marking breakthrough for ultra-rare immunodeficiency patients.
Henlius and Organon's POHERDY Becomes First Pertuzumab Biosimilar Approved in Europe
European Commission approves POHERDY as first pertuzumab biosimilar in Europe, offering cost-effective alternative to PERJETA for breast cancer treatment.