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.
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.
NMPA Conditional Approval: What You Need to Know About China's Expedited Drug Pathway
Learn about China's NMPA Conditional Approval process, designed to expedite access to critical medications like XYZ for cancer patients.
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.
NMPA Conditional Approval Pathway: Impact on Innovative Oncology Drug Access
The NMPA Conditional Approval Pathway significantly enhances access to innovative oncology drugs, facilitating timely treatment options for cancer patients.