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.
Arrowhead Pharmaceuticals Receives TGA Approval for REDEMPLO (Plozasiran) in Australia for Rare Metabolic Disorder
Arrowhead Pharmaceuticals' REDEMPLO (plozasiran) receives Australian TGA approval for familial chylomicronemia syndrome, expanding global access.
Novo Nordisk Launches Wegovy in China Before Eli Lilly, Capturing World's Largest Obesity Market
Novo Nordisk secures first-mover advantage launching Wegovy in China ahead of Eli Lilly's competing obesity drug, targeting massive untapped market opportunity.
BioMarin's PALYNZIQ Receives FDA Approval for Adolescent PKU Patients 12 and Older
BioMarin announces FDA approval of PALYNZIQ for adolescents 12+ with phenylketonuria (PKU), expanding treatment options for rare genetic disorder patients.
FDA Approves Travere's FILSPARI for FSGS Treatment in Adults and Children 8+
Travere Therapeutics receives FDA approval for FILSPARI to reduce proteinuria in FSGS patients aged 8 and older, expanding rare kidney disease treatment options.
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.
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.
Apotex Receives First Canadian Health Canada Approval for Generic Ozempic (Semaglutide) Alternative
Apotex becomes first Canadian pharmaceutical company to receive Health Canada approval for Apo-Semaglutide Injection, a generic equivalent of Ozempic.
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.
Claruvis Pharmaceutical's Retoxin Becomes World's First Approved Recombinant Botulinum Toxin Type A in China
China's NMPA approves Retoxin, the world's first recombinant botulinum toxin type A, marking a technological breakthrough in aesthetic medicine treatments.
MorphoSys' MINJUVI (Tafasitamab) Approved in Australia for Relapsed/Refractory Follicular Lymphoma
Australia approves MINJUVI (tafasitamab) as first chemotherapy-free dual-targeted immunotherapy for relapsed/refractory follicular lymphoma patients.
Hengrui Pharma Q1 2026 Results: Anti-PD-L1/TGF-βRII Fusion Protein Approved in China
Hengrui Pharma reports Q1 2026 growth with three innovative drug approvals including breakthrough anti-PD-L1/TGF-βRII bi-functional fusion protein in China.