Sino Biopharma’s benmelstobart-anlotinib Combo Wins NMPA Nod for First-Line sq-NSCLC
Sino Biopharmaceutical Limited (HKG: 1177) announced that benmelstobart in combination with chemotherapy, sequentially followed by anlotinib,...
Product approvals
Takeda Expands Revestive Approval in China with New 1.25 mg Specification for Pediatric Short Bowel Syndrome Patients as Young as 4 Months
Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that China’s National Medical Products Administration...
Hengrui Pharmaceuticals Secures Fifth NMPA Approval for Ivarmacitinib in Non-Radiographic Axial Spondyloarthritis
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its self-developed Class 1...
Westlake Consortium Secures NMPA Approval for Iscartrelvir, Novel Oral 3CLpro Inhibitor for Mild-to-Moderate COVID-19
The Category 1 innovative drug Iscartrelvir, jointly developed by Westlake University, Westlake Laboratory, and Westlake...
Hengrui Pharmaceuticals Secures Third NMPA Approval for Trastuzumab Rezetecan in HER2-Positive Colorectal Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that its HER2-targeting antibody-drug conjugate...
TransThera Sciences Secures NMPA Conditional Approval for Tinengotinib in Advanced Cholangiocarcinoma with FGFR2 Alterations
TransThera Sciences (HKG: 2617) announced that China’s National Medical Products Administration (NMPA) has granted conditional...
Takeda Receives FDA Approval for ORZEYFUL (oveporexton), First Oral OX2R Agonist for Narcolepsy Type 1 in Adults
Takeda Pharmaceutical Company Limited (TYO: 4502; NYSE: TAK) announced that the U.S. Food and Drug...
Sanofi Secures European Commission Approval for MenQuadfi Pediatric Indication Extension to Infants from Six Weeks of Age
Sanofi (NASDAQ: SNY) announced that the European Commission (EC) has approved an extension of the...
FDA Grants Biologics License to Ezplaz Freeze-Dried Plasma, First FDP Approved in United States
On July 29, 2026, the U.S. FDA granted a biologics license to Ezplaz Freeze Dried...
Novartis’ Pluvicto Receives FDA Approval for Metastatic Hormone-Sensitive Prostate Cancer
Novartis (NYSE: NVS) announced that the U.S. Food and Drug Administration (FDA) has approved Pluvicto...
Sansure Biotech Secures EU IVDR CE Certification for Five Nucleic Acid Diagnostic Kits
Sansure Biotech Inc. (SHA: 688289) announced that five of its nucleic acid diagnostic kits have...
BrightGene’s Generic Tiotropium Bromide Inhalation Spray Gains NMPA Approval as China’s First Domestic COPD Treatment Alternative
BrightGene (Suzhou) Co., Ltd. (SHA: 688166) announced that its tiotropium bromide inhalation spray has received...
Roche’s Vabysmo Wins NMPA Approval for Retinal Diseases in China Market Expansion
Roche Holding AG (SWX: ROP; OTCMKTS: RHHBY) announced that China’s National Medical Products Administration (NMPA)...
Huahai Pharmaceutical’s Anti-IL-36R Antibody Huayijing Receives NMPA Priority Review Approval for Generalized Pustular Psoriasis Flares
Zhejiang Huahai Pharmaceutical Co., Ltd. (SHA: 600521) announced that its Category 1 therapeutic biologic HB0034...
Gilead’s Trodelvy Receives Positive CHMP Opinion for First-Line TNBC Treatment in Combination with Keytruda
Gilead Sciences Inc. (NASDAQ: GILD) announced that the Committee for Medicinal Products for Human Use...
Walvax Biotechnology’s Bivalent HPV Vaccine WALRINVAX Gains Tanzanian Approval Following WHO Prequalification
Walvax Biotechnology Co., Ltd. (SHE: 300142) announced today that its bivalent human papillomavirus (HPV) vaccine...
Aidea Pharma Secures NMPA Approval for Darunavir, Challenging J&J’s Prezista in China’s HIV Treatment Market
Jiangsu Aidea Pharmaceutical Group Co., Ltd. (SHA: 688488) announced today that China’s National Medical Products...
Hengrui Pharmaceuticals Secures NMPA First-Line Approval for Camrelizumab-Famitinib Combo in PD-L1-Positive Cervical Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced today that China’s National Medical...
AstraZeneca’s Etcamah Wins EU Approval for ESR1-Mutated Breast Cancer – Next-Gen SERD Shows 56% Risk Reduction in Pivotal Trial
AstraZeneca plc (NYSE: AZN) announced that the European Union has granted marketing authorization for Etcamah...
GSK Secures Early FDA Approval for Jideytro – ROS1 Inhibitor for Resistant Non-Small Cell Lung Cancer
GlaxoSmithKline plc (GSK) (NYSE: GSK) announced on July 22, 2026 that the U.S. Food and...