Regulatory Approvals
Page 1 • 8 itemsTrack global regulatory approvals for new drugs and biologics. Stay ahead in pharma BD with critical FDA, EMA, and PMDA insights.
Arrowhead Pharmaceuticals Receives TGA Approval for REDEMPLO (Plozasiran) in Australia for Rare Genetic Disorder
Arrowhead Pharmaceuticals gains Australian TGA approval for REDEMPLO (plozasiran), expanding global access for familial chylomicronemia syndrome patients.
FDA Approves Auvelity: A New Option for MDD
The FDA has approved Auvelity, a new oral antidepressant combining bupropion and dextromethorphan, for the treatment of major depressive disorder (MDD) in adults. Manufactured by Axsome Therapeutics, this approval marks a significant advancement in MDD treatment options.
FDA Approves Auvelity for MDD: A New Antidepressant Option
The FDA has granted approval for Auvelity, a new oral medication for major depressive disorder (MDD) in adults. This approval introduces a novel treatment option with a distinct mechanism of action and a reported rapid onset of therapeutic effect.
Auvelity FDA Approval: New MDD Treatment Option
The FDA has approved Auvelity, a new oral antidepressant from Axsome Therapeutics, offering a novel mechanism of action for adults with major depressive disorder (MDD). This landmark approval signifies a significant advancement in depression treatment options.
FDA Approves Auvelity for MDD: Axsome Therapeutics' New Antidepressant
The FDA has approved Auvelity (dextromethorphan and bupropion) from Axsome Therapeutics for the treatment of major depressive disorder (MDD) in adults. This marks a significant advancement in MDD therapy with a new mechanism of action.
Plozasiran TGA Approval: REDEMPLO® Approved in Australia for FCS
Arrowhead Pharmaceuticals announced the TGA approval of REDEMPLO® (plozasiran) in Australia for the treatment of Familial Chylomicronemia Syndrome (FCS). This significant milestone expands global access to a novel therapy for patients with this rare genetic disorder.
BioMarin Completes $3 Billion Acquisition of Amicus Therapeutics, Expands Rare Disease Portfolio with Galafold and Pompe Therapies
BioMarin's acquisition of Amicus adds globally approved Galafold for Fabry disease and POMBILITI/OPFOLDA combination for Pompe disease to its rare disease pipeline.
Sonorous Neurovascular Receives FDA 510(k) Clearance for BosCATH™ Neurovascular Catheter
Sonorous Neurovascular gains FDA 510(k) clearance for BosCATH™ catheter, advancing neurovascular intervention capabilities for complex cerebral procedures.