News
🌏 Asia-PacificLatest pharmaceutical news, drug approvals, and NMPA regulatory updates
Latest News
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.
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.
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.
Keenova Therapeutics Presents New TERLIVAZ Clinical Data for Hepatorenal Syndrome at Digestive Disease Week 2026
Keenova Therapeutics shares new TERLIVAZ (terlipressin) clinical analysis for hepatorenal syndrome-acute kidney injury at DDW 2026, expanding treatment evidence.
Kodiak Sciences KSI-101 Clinical Data to Be Presented at Scientific Conferences for Macular Edema Treatment
Kodiak Sciences will present KSI-101 clinical data for macular edema secondary to inflammation, with Phase 3 results expected in Q4 2026.
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.
NAMSA and Lexitas Form Strategic Partnership for Comprehensive Ophthalmic Medical Device Development Services
NAMSA partners with Lexitas Pharma Services to offer end-to-end ophthalmic medical device development, creating single-source solution for sponsors.
Verified Clinical Trials Partners with Chubb to Enhance Patient Safety and Data Quality in Clinical Research
Verified Clinical Trials and Chubb announce strategic alliance to improve clinical trial participant safety, data quality, and study integrity worldwide.
Huahui Health Partners with BeOne Medicines for HH160 Trispecific Antibody in Global Oncology Deal
Huahui Health grants BeOne Medicines exclusive worldwide rights to develop HH160, a novel trispecific antibody for cancer immunotherapy treatment.
Amgen Reports Strong Q1 2026 Financial Results with 16 Brands Achieving Double-Digit Growth
Amgen's Q1 2026 results show robust performance with 16 brands posting double-digit growth, offsetting patent expirations and increased competition.
Haier Biomedical Reports Record 36% International Revenue Growth in Life Science Infrastructure Market
Haier Biomedical achieves 36% international revenue share with $340.77M total revenue, driving AI-powered life science infrastructure expansion globally.
TGA Issues Guidance on Combination and Boundary Products for Pharmaceutical Companies in APAC
Australia's TGA provides regulatory clarity on combination products like pre-filled syringes and boundary products including nasal decongestants.
Genprex Receives Israel Patent for Reqorsa Gene Therapy Combined with PD-1 Antibodies in Cancer Treatment
Genprex secures Israeli patent protection for Reqorsa gene therapy combination with PD-1 antibodies, strengthening intellectual property portfolio for cancer treatment.