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🌏 Asia-PacificLatest pharmaceutical news, drug approvals, and NMPA regulatory updates.
Breaking 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.
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Telix Pharmaceuticals' TLX250-Px Shows Promise for Diagnosing Multiple Kidney Cancer Types Beyond Clear Cell RCC
New Phase 3 ZIRCON analysis reveals TLX250-Px (Zircaix®) potential for diagnosing various kidney cancers, expanding beyond clear cell renal cell carcinoma applications.
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.
Mifepristone Access Continues Under Supreme Court Hold as Planned Parenthood Responds to 5th Circuit Ruling
Planned Parenthood can continue dispensing Mifepristone by mail and certified pharmacies until May 11 following Supreme Court provisional hold on 5th Circuit ruling.
XtalPi-Enabled PEP08 PRMT5 Inhibitor Begins Phase I Cancer Trial Enrollment
XtalPi and PharmaEngine's AI-discovered PRMT5 inhibitor PEP08 starts Phase I solid tumor trial, marking major milestone in synthetic lethality cancer treatment.
SPONTAN Phase II Data Shows 10-Minute Onset Time, Meets FDA Requirements for Erectile Dysfunction Treatment
SPONTAN Phase II interim results demonstrate 10-minute median onset versus 60 minutes for oral vardenafil, meeting FDA pharmacokinetic requirements.
Ironwood Pharmaceuticals Survey Reveals Critical Gaps in Short Bowel Syndrome TPN Treatment at DDW 2026
Ironwood Pharmaceuticals presents DDW 2026 survey findings highlighting unmet needs in total parenteral nutrition therapy for short bowel syndrome patients.
Edwards Lifesciences RESILIA Tissue Shows 10-Year Durability in COMMENCE Aortic Trial Results
Edwards Lifesciences announces 10-year COMMENCE trial data demonstrating long-term durability of RESILIA tissue for aortic valve replacement procedures.
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.
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.
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.
ROIS Expands to US Market as Global CDMO with FDA Approval for Injectable Drug Manufacturing
ROIS establishes US operations as global CDMO with FDA, EMA, and other major regulatory approvals for end-to-end injectable drug manufacturing services.
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.
Sun Pharma Organon Partnership to Expand Access to Key Medicines
Sun Pharma has announced a strategic partnership with Organon to commercialize five of Organon's established products across India. This collaboration aims to leverage Sun Pharma's extensive network to improve patient access to vital treatments.
UCB Acquires Candid Therapeutics for $2.2 Billion, Expanding T-Cell Engager Platform for Autoimmune Diseases
UCB's $2.2B acquisition of Candid Therapeutics brings novel T-cell engager technology for autoimmune diseases, marking major expansion beyond oncology applications.
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.
a2 Milk Company Recalls Three Batches of a2 Platinum Infant Formula Due to Health Risk Concerns
a2 Milk Company voluntarily recalls three batches of a2 Platinum Premium USA infant formula for 0-12 months due to potential health risks to babies.
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.
Vector Science & Therapeutics Files Patent for Microneedle Catheter Platform for Cancer Drug Delivery
Vector Science & Therapeutics secures IP protection for novel microneedle catheter technology designed to deliver cancer drugs directly into tumors.
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.