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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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Cryoport Q1 2026 Results: Revenue Jumps 26% Supporting Record 766 Clinical Trials and 21 Commercial Cell Gene Therapies
Cryoport reports 26% revenue growth in Q1 2026, supporting a record 766 global clinical trials and 21 commercially approved cell and gene therapies worldwide.
Ascidian Therapeutics Completes ACDN-01 Dose Escalation in STELLAR Phase 1/2 Trial for Stargardt Disease
Ascidian Therapeutics completes adult dose escalation for ACDN-01 in Stargardt disease Phase 1/2 STELLAR trial, expands to pediatric patients.
Quiver Bioscience Receives NIH HEAL Initiative Grant for QV-2421 Chronic Pain Therapy Clinical Trials
Quiver Bioscience secures NIH HEAL Initiative funding to advance QV-2421, a Nav1.7 antisense therapy for chronic pain, through IND studies and human trials.
Lunai Bioworks Raises $20 Million to Acquire CNS Drug Delivery Technology for Alzheimer's Treatment
Lunai Bioworks completes $20M preferred equity raise to acquire CNS delivery tech and neurotherapeutic IP, expanding Alzheimer's disease treatment platform.
Stryker Australia Receives TGA Approval for Total Temporomandibular Joint Prosthesis
Stryker Australia gains TGA approval for total temporomandibular joint prosthesis, expanding treatment options for TMJ disorders in Australia.
Australia's TGA Section 41HD Emergency Medical Device Import Approvals: Complete Guide for Healthcare Providers
Australia's TGA Section 41HD approvals enable emergency medical device imports during supply shortages. Learn eligibility criteria and application process.
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.