AstraZeneca’s Ultomiris Approved in China for Generalized Myasthenia Gravis
UK-based pharmaceutical giant AstraZeneca (NASDAQ: AZN) has announced that the National Medical Products Administration (NMPA)...
Drug
Zai Lab’s Augtyro NDA Accepted by China’s NMPA for NTRK Fusion Solid Tumors
China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that the supplemental New Drug...
Viatris Submits Marketing Application for Effexor SR in Japan for Generalized Anxiety Disorder
Viatris Inc. (NASDAQ: VTRS) announced the submission of a marketing application to Japan’s Ministry of...
Bio-Thera Solutions Gains NMPA Clinical Approval for BAT7111 in Advanced Solid Tumors
China-based Bio-Thera Solutions Inc. (SHA: 688177) has announced that it has received clinical approval from...
Ascentage Pharma’s Oncology Drugs Lisaftoclax and Olverembatinib Gain CSCO Guidelines Inclusion
China-based Ascentage Pharma (NASDAQ: AAPG, HKG: 6855) announced that its two innovative drugs have been...
Gan & Lee’s GZR102 Receives NMPA Clinical Trial Clearance for Type 2 Diabetes
China’s Gan & Lee Pharmaceuticals (SHA: 603087) announced that it has received clinical trial clearance...
Regeneron’s Eylea HD Receives FDA Complete Response Letter Despite Priority Review
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that it has received a Complete Response Letter (CRL)...
Hengrui Gains NMPA Approval for Phase III Study of SHR-8068 in PD-L1 Negative NSCLC
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has received approval from the National Medical...
Kelun-Biotech Gains FDA Clearance for Phase I Trial of ADC SKB518
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced that it has received clearance from the...
Grand Pharma’s GPN02006 Shows Promising HCC Diagnostic Results in Trial
China-based Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has reported excellent outcomes from the investigator-initiated...
Novo Nordisk’s Wegovy Gets NMPA Label Update for Cardiovascular Risk Reduction
China’s National Medical Products Administration (NMPA) has approved a label update for Novo Nordisk’s (NYSE:...
Rona Therapeutics Wins NMPA IND Approval for siRNA Hypertension Drug RN1871
Shanghai-based Rona Therapeutics Inc., a developer of siRNA medicines, has announced that it has received...
HutchMed Completes Patient Enrollment for Orpathys in Gastric Cancer Trial
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) announced the completion of patient enrollment for the...
Akeso’s Ebdarokimab Receives NMPA Approval for Moderate to Severe Plaque Psoriasis
China’s Akeso Biopharma (HKG: 9926) announced that it has received marketing approval from the National...
Belief BioMed Gains NMPA Clinical Trial Approval for DMD Gene Therapy BBM-D101
China-based gene therapy specialist Belief BioMed Inc. (BBM) has announced that it has received clinical...
Sanofi’s Dupixent Approved by FDA for Chronic Spontaneous Urticaria
France-based pharmaceutical major Sanofi (EPA: SAN, NASDAQ: SNY) has announced that the US Food and Drug...
Biogen’s High-Dose Spinraza Regimen Accepted for CDE Review in China
US-based Biogen Inc. (NASDAQ: BIIB) announced that the Center for Drug Evaluation (CDE) in China...
Sichuan Biokin Gains NMPA Approval for Phase II Trials of BL-B01D1 in Combination Therapies
China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has received approval from the National Medical...
Walvax Biotech Gains NMPA Clinical Clearance for 20-Valent Pneumococcal Vaccine
China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced receiving clinical trial clearance from the...
Dizal’s Golidocitinib Receives CSCO Class 1 Recommendation for PTCL Treatment
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) announced that its drug Gaoruizhe (golidocitinib) has received...