FDA Clears Elevidys Gene Therapy After Investigating 8-Year-Old Boy’s Death
The U.S. Food and Drug Administration (FDA) has completed its investigation into the death of...
Mabwell’s CDH17-Targeted ADC 7MW4911 Receives Clinical Trial Approval in China and IND Clearance in the US
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that its self-developed CDH17-targeted antibody-drug conjugate...
Cutia Therapeutics’ CU-40102 Approved in Hong Kong for Androgenetic Alopecia Treatment
China-based dermatology specialist Cutia Therapeutics (HKG: 2487) announced today that its CU-40102 (finasteride topical spray)...
UTC Therapeutics Gains FDA Clearance for CAR-T Therapy UCLM805 in MSLN-Positive Solid Tumors
China-based cell therapy biotech UTC Therapeutics announced receiving clearance from the US Food and Drug...
FDA Mandates Safety Labeling Changes for Opioid Pain Medications and Targets 7-OH Products
The U.S. Food and Drug Administration (FDA) is implementing new safety measures for opioid pain...
Luye Pharma’s LY03021 Completes Enrollment of First Healthy Subject in Phase I Trial
China-based Luye Pharma Group (HKG: 2186) announced on August 3, 2025, that its self-developed Class...
AllianThera Partners with Dr. Falk Pharma to Develop ATB102 for Ulcerative Colitis
China-based AllianThera Biopharma (ATB) announced a strategic partnership with Germany’s Dr. Falk Pharma GmbH to...
Grand Pharma Partners with IRE EliT to Distribute 68Ge/68Ga Generators in China
On July 31, 2025, China-based Grand Pharmaceutical Group Limited (HKG: 0512) announced a strategic collaboration...
Lee’s Pharma’s Socazolimab Approved by NMPA for ES-SCLC First-Line Treatment
Lee’s Pharmaceutical Holdings Ltd. (HKG: 0950) announced that its in-licensed programmed-death ligand 1 (PD-L1) monoclonal...
BrightGene and CR Sanjiu Collaborate on BGM0504 Injection Development and Commercialization
China-based BrightGene Bio-Medical Technology Co., Ltd. (SHA: 688166) and its affiliated companies announced a collaboration...
AbbVie Reports Strong Q2 2025 Results With Immunology Portfolio Leading Growth
US-based multinational AbbVie Inc. (NYSE: ABBV) reported strong Q2 2025 results with global revenues increasing...
BMS Q2 Earnings Reflect Strategic Investments; Maintains Full-Year Revenue Growth Outlook
US major Bristol-Myers Squibb (BMS; NYSE: BMY) reported Q2 2025 financial results, revealing total revenues...
China’s NHSA Issues Rules for Instant Settlement of Medical Insurance Funds
China’s National Healthcare Security Administration (NHSA) has issued the “Interim Administrative Rules for Instant Settlement...
Hybio and BrightGene Partner on Peptide Raw Material Supply for Global Drug Commercialization
China-based Hybio Pharmaceutical Co., Ltd. (SHE: 300199) and China-based BrightGene Bio-Medical Technology Co., Ltd. (SHA:...
BeOne Medicines’ BGB-16673 Granted PRIME Designation by EMA for Waldenström’s Macroglobulinemia
China-based BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced on July 31, 2025,...
Neurodawn’s Subsidiary Receives NMPA Approval for First LHI Treatment RK-4 Injection
China-based Neurodawn Pharmaceutical Co., Ltd.’s wholly-owned subsidiary, Fuzhou Ningdan Rongkang Biomedical Technology Co., Ltd. (Ningdan...
NMPA Seeks Public Feedback on Draft Regulations for Internet Drug and Medical Device Information Services
On July 31, 2025, China’s National Medical Products Administration (NMPA) commenced soliciting public comments on...
Haisco’s Ciprofol NDA Accepted by FDA: A Milestone for Chinese Anesthesia Innovation
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) announced that the New Drug Application (NDA)...
AstraZeneca’s Ultomiris Gains NMPA Approval for Neuromyelitis Optica Spectrum Disorder
UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) announced that China’s National Medical Products Administration (NMPA)...
Chipscreen’s Next-Gen Brain-Penetrant Aurora B Inhibitor CS231295 Gains FDA Clearance for Advanced Solid Tumors
On July 31, 2025, the investigational new drug (IND) application for Shenzhen Chipscreen Biosciences Co.,...