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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

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

Protagonist Therapeutics and Takeda Report Positive Phase 3 Results for Rusfertide in PV, Meeting All Primary and Secondary Endpoints

Rusfertide plus current standard of care more than doubled clinical response rates across high- and low-risk PV groups, significantly reducing phleboto...

June 03, 2025 | News

NICE Recommends CSL Vifor’s Sparsentan for Routine Use in Treating IgA Nephropathy in England

CSL Vifor is pleased to announce that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending tha...

May 26, 2025 | News

AnnJi Reports Promising Phase 1/2a Results for AJ201 in Rare Neuromuscular Disease SBMA

AnnJi Pharmaceutical Co., Ltd., a clinical-stage Taiwanese biotechnology company focused on addressing unmet medical needs in dermatology, neurology, and r...

May 22, 2025 | News

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