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.
Orchard Therapeutics OTL-201: Innovation Passport for MPS-IIIA
Orchard Therapeutics has secured an Innovation Passport designation from the MHRA for its investigational gene therapy, OTL-201, targeting MPS-IIIA. This marks a significant step in accelerating development and access for patients with Sanfilippo syndrome type A.
MHRA Post-Brexit Drug Approval: What You Need to Know
Learn about the MHRA's new drug approval process post-Brexit and its impact on the availability of essential medications like Ozempic for diabetes.
MHRA Drug Approval Divergence: UK vs EU Market Access & Investment Impact
This article delves into the differences in MHRA drug approval processes for [Drug Name] in [Indication], highlighting their effects on market access and investment strategies in the UK and EU.
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.
Auvelity FDA Approval: A New MDD Treatment Option
The FDA has approved Auvelity, a novel oral therapy from Axsome Therapeutics, for the treatment of major depressive disorder (MDD). This marks a significant advancement in MDD treatment options.
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.