Drug Approvals News

PMDA approves ENHERTU for HER2-low breast cancer in Japan

5 min

TGA Australia drug approval pharmaceutical: what the regulator is

TGA · 4 min

PMDA Regulatory Updates: New Orphan Drug Portal and ASEAN Symposium Open

PMDA · 4 min

NMPA China FDA Drug Approval: 2026 Pathways, Timelines & Impact

FDA · 4 min

Vietnam and India Reshape Middle Power Diplomacy: Market Analysis for Pharma

6 min

NMPA Drug Approvals Surge in 2025: Record 61 First Global Approvals Signal Accelerated Market Access

National Medical Products Administration · 4 min

Building a Smarter Medical Devices Ecosystem in India: Regulatory Updates

FDA · healthcare technologies · 5 min

A Decade of AI Medical Device Regulation: Key Updates for Pharma

FDA · 4 min

Cell and Gene Therapy Approvals in China: Latest Regulatory Updates

FDA · gene therapy · 5 min

Regulatory Round-Up: Key Drug Approvals on May 18, 2026

FDA · 5 min

Optical Coherence Tomography Gains Regulatory Traction in Pharma Filings

FDA · 6 min

Datroway Approved: A New Hope for Metastatic TNBC Patients

FDA · metastatic TNBC · 5 min