Bayer’s Sevabertinib Receives FDA Priority Review for HER2-mutant NSCLC
German pharmaceutical giant Bayer AG (ETR: BAYN) announced that its investigational oral small-molecule tyrosine kinase...
JW Therapeutics’ Carteyva Receives Fourth sBLA for r/r LBCL
JW Therapeutics (HKG: 2126), a clinical-stage cell therapy company co-founded in 2016 by Juno Therapeutics...
Sino Medical Sciences Technology’s AUCURA Flow-Diverting Stent Approved by NMPA
China-based Sino Medical Sciences Technology Inc. (SHA: 688108) announced that its holding subsidiary Neurovita has...
Changchun Pharma Wins FDA Approval for GenSci128 in TP53 Y220C Solid Tumors
China-based Changchun High & New Technology Industries (Group) Inc., (SHE:000661) announced that its subsidiary Changchun...
Yantai Dongcheng Pharma Gains NMPA Approval for Sodium Fluoride [18F]
China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has received marketing approval from the...
Guided Therapeutics Receives Payment from Shandong Yaohua for LuViva Commercialization
US-based Guided Therapeutics, Inc. (OTCMKTS: GTHP), a developer of rapid, painless testing platforms based on...
RemeGen’s Telitacicept Approved for Myasthenia Gravis in China
China-based pharmaceutical firm RemeGen (HKG: 9995) announced the third indication approval from the National Medical...
Biogen and City Therapeutics Collaborate on RNAi Therapies for CNS Diseases
US-based Biogen Inc. (NASDAQ: BIIB) announced a strategic collaboration with compatriot firm City Therapeutics, Inc....
HKSH Medical Partners with United Imaging to Advance CT Technology
Hong Kong-based private healthcare provider HKSH Medical Group announced the signing of a Memorandum of...
AstraZeneca’s Imfinzi Gets Positive Opinion for Bladder Cancer Perioperative Treatment
UK-based pharmaceutical giant AstraZeneca (AZ; NASDAQ: AZN) announced that the European Medicines Agency’s (EMA) Committee...
EyePoint’s Partner Betta Completes Enrollment for Duravyu’s Pivotal Phase III Study
EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), the US partner of China-based Betta Pharmaceuticals (SHE: 300558), announced...
EMA Recommends Tevimbra for Nasopharyngeal Cancer First-line Treatment
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended...
AbelZeta Pharma’s C-CAR168 Secures FDA RMAT Designation for Lupus Treatments
Sino-US biotech AbelZeta Pharma, Inc., based in Rockville, Maryland, and with operations in Shanghai, announced...
FDA Rejects Data from Two Chinese Testing Labs Over Compliance Concerns
The U.S. Food and Drug Administration (FDA) late last week issued General Correspondence Letters to...
CARsgen’s Satricabtagene Autoleucel Granted Priority Review by China’s CDE
China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced that the Center for Drug Evaluation...
Salubris Pharma’s Xinchaotuo Gains NMPA Approval for Primary Hypertension
China-based Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) announced that it has received marketing approval...
Jiangsu Nhwa’s Investee Jiangsu Haoxinqing Plans Overseas Listing
China-based Jiangsu Nhwa Pharmaceutical Co., Ltd (SHE: 002262) announced that its investee company Jiangsu Haoxinqing...
Shenyang Xingqi Pharmaceuticals Plans Private Placement to Fund R&D Center
China-based Shenyang Xingqi Pharmaceutical Co., Ltd (SHE: 300573) announced plans for a private placement of...
Novartis’ Beovu Approved by NMPA for Diabetic Macular Edema Treatment
Swiss giant Novartis’ (NYSE: NVS) Beovu (brolucizumab) received approval from China’s National Medical Products Administration...
Mabworks’ MIL62 Gains NMPA Review for NMOSD Treatment
China-based Beijing Mabworks Biotech Co., Ltd announced that its New Drug Application (NDA) for MIL62,...