Bio Special Special Report
Using NLP-Driven Decision Support in Emergency Health Assistance
According to the US Department of Transportation, over 40,000 lives were lost in roadway deaths in 2023. The CDC reports that the country saw appro...
July 14, 2025 | News
FDA Publishes First-Ever Public Database of Complete Response Letters (2020–2024) – Now Available for Download
Download Approved CRLs – 2020 to 2024 (external link) U.S. Food and Drug Administration (FDA) has, for the first time, made pub...
July 14, 2025 | Regulatory
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
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