FDA Accelerates Approval of Dordaviprone for H3 K27M-Mutant Diffuse Midline Glioma
The U.S. Food and Drug Administration (FDA) granted accelerated approval on August 6, 2025, to...
Drug
Hengrui Pharmaceuticals Gains NMPA Approval for SHR-7782 Clinical Trials in Advanced Solid Tumors
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that its independently developed therapeutic...
FDA Approves Precigen’s Papzimeos for Recurrent Respiratory Papillomatosis”
The U.S. Food and Drug Administration (FDA) has approved Papzimeos (zopapogene imadenovec-drba), developed by Precigen,...
Sanofi’s Rilzabrutinib Granted Orphan Drug Designation for IgG4-Related Disease by EMA
French pharmaceutical major Sanofi (NASDAQ: SNY) announced that it has received another orphan drug designation...
Pfizer’s Emblaveo Prescribed in Shanghai Hospitals for First Time Nationwide
US giant Pfizer Inc. (NYSE: PFE) announced that its Emblaveo (aztreonam and avibactam) has been...
Insilico Medicine’s ISM8969 Nears Clinical Evaluation for Parkinson’s Disease
Insilico Medicine, a Chinese generative AI-driven biotech company, announced the completion of IND-enabling studies for...
SineuGene’s First-in-Class ALS Gene Therapy SNUG01 Gets NMPA Clinical Trial Clearance
Beijing-based SineuGene Therapeutics, a developer of gene therapies for brain disorders based in Beijing, announced that...
Eli Lilly Hikes Mounjaro Price in UK by 170% for Private-Pay Patients
US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) announced on August 14, 2025, that...
Qihan Biotech’s QT-019B Gains FDA IND Approval for Autoimmune Diseases
Hangzhou Qihan Biotech Co., Ltd. announced that its self-developed universal dual-target CAR-T cell product, QT-019B,...
Novartis’ Ianalumab Shows Positive Results in Phase 3 Trials for ITP and Sjögren’s Disease
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced positive top-line results from the Phase 3 VAYHIT2...
Everest Medicines’ Velsipity NDA Accepted for Review in Taiwan
China-based Everest Medicines (HKG: 1952) announced that the New Drug Application (NDA) for its Velsipity...
Hualan Biological Gains NMPA Approval for Hib Vaccine Clinical Trials
Hualan Biological Engineering Inc., (SHE: 002007) announced that its freeze-dried Haemophilus influenzae type b (Hib)...
RemeGen Announces Positive Phase III Results for Telitacicept in Primary Sjögren’s Syndrome
China-based RemeGen Co., Ltd. (SHA: 688331, HKG: 9995), a China-based pharmaceutical firm, announced on August...
MSD Officially Launches Zerbaxa in China to Tackle Drug-Resistant Infections
US-based Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK) announced on August 13, 2025, the...
Jiangsu Hengrui’s Combo Therapy Approved for Clinical Trials by NMPA
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced on August 13, 2025,...
Henlius Biotech’s HLX04-O Accepted by NMPA for Wet AMD Treatment
Shanghai Henlius Biotech Inc. (HKG: 2696) announced on August 13, 2025, that the marketing authorization...
TYK Medicines’ Asandeutertinib Shows Promising Results in Phase II Trial for EGFR-Mutated NSCLC
China-based TYK Medicines, Inc. (HKG: 2410) announced on August 14, 2025, that the results of...
Hengrui Pharmaceuticals Expands Hetrombopag Olamine’s Indication for ITP Patients
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (HKG: 1276, SHA: 600276) announced that the indication expansion for...
Sino Biopharmaceutical’s TQB3142 IND Application Accepted by China’s NMPA for Malignant Tumor Treatment
Sino Biopharmaceutical Limited (HKG: 1177) announced that the Investigational New Drug (IND) application for TQB3142,...
Novartis’ Leqvio Approved by FDA as Standalone Therapy for Hypercholesterolemia
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced on August 12, 2025, that the U.S. Food...