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Special Report

No More Whisper Networks: FDA Puts Its Rejection Reasons in Writing — Publicly

FDA Embraces Radical Transparency by Publishing Complete Response Letters For Immediate Release: July 10, 2025 &nb...

July 11, 2025 | News

FDA’s Most Recent 100 Warning Letters of 2025 Signal Rising Compliance Risks Across Pharma, Biologics, Devices, Food, and Online Markets

As of July 2025, the U.S. Food and Drug Administration (FDA) has issued over 3,400 warning letters, with the most recent 100 painting a vivid pictu...

July 11, 2025 | Analysis | By BioPharma APAC Desk

FDA Finalises Guidance on Drug Development for Early Lyme Disease: A Strategic Signal for Industry Innovation

This finalised guidance serves as a blueprint for biopharmaceutical developers aiming to address early manifestations of Lyme disease—particularly ea...

July 11, 2025 | Analysis | By BioPharma APAC Desk

The Role of Unique Device Identification (UDI) in Tracing Medical Device Safety

According to GlobeNewswire, this vital sector is projected to reach an impressive $756.59 billion by 2031, exhibiting a CAGR of 5.8% from 2024 to 2031. How...

July 02, 2025 | Report

Southeast Asia Poised to Lead AI-Driven Healthcare Transformation Amid Rising Cross-Border Collaboration

The Southeast Asia (SEA) region’s role in healthcare innovation, long bolstered by Singapore’s commitment to serve as a g...

July 01, 2025 | Opinion | By Chu Canh Chieu, FPT Software Managing Director of Global Healthcare Center, FPT Corporation

Innovent Biologics Secures NMPA Approval for World’s First Dual GCG/GLP-1 Receptor Agonist Mazdutide for Weight Management in China

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality me...

June 30, 2025 | News

Alebund Pharmaceuticals Achieves Phase 3 Success with AP301 for Hyperphosphatemia in Dialysis Patients

Alebund Pharmaceuticals ("Alebund" or the "Company"), an integrated biopharmaceutical company focusing on developing innovative therapies for renal di...

June 27, 2025 | News

Thermo Fisher’s Integrated CDMO-CRO Model Cuts Drug Development Time by Up to 34 Months, Finds Tufts CSDD Study

Thermo Fisher Scientific Inc., the world leader in serving science, announced the findings of new research by the Tufts Center for the Study of Drug ...

June 17, 2025 | News

66 Percent of APAC Patients Face Specialist Delays as Philips Urges Trust in AI to Ease Healthcare Pressures

66% of patients surveyed in APAC are experiencing delays in seeing specialist doctor, with an average waiting time of 47 days 89% of healt...

June 13, 2025 | Report

Eluminex Reports Positive Phase 1 Results for EB-105 in Diabetic Macular Edema Patients

EB-105 Targets VEGF-A, -B, PlGF, Ang-2, and IL-6R Improvements in Visual Acuity and Retinal Edema Observed at All Dose Levels No Safety Issues Observed...

June 10, 2025 | News

New Studies Presented at ERA 2025 Reinforce NEFECON®’s Early Intervention Value in IgA Nephropathy

Two new studies on NEFECON® demonstrate its treatment benefit in the "Treat Early" strategy for IgA nephropathy (IgAN), providing robust su...

June 09, 2025 | News

ASCO 2025 Showcases New Oncology Paradigms, From Breast Cancer Breakthroughs to AI-Led Precision Medicine

The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting wasn’t just another scientific gathering and it was a seismic event that redrew ...

June 06, 2025 | Report

Innovent Secures Second NMPA Breakthrough Therapy Designation for IBI363 in Advanced Lung Cancer

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality m...

June 05, 2025 | News

Transgene and NEC Report Sustained Disease-Free Survival With TG4050 in Head and Neck Cancer at ASCO 2025

Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (...

June 03, 2025 | News

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