Huadong Medicine’s SaiYueXin Biosimilar Accepted for Review by NMPA for Pediatric Psoriasis
Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration (NMPA)...
Market approval filings
Hansoh Pharmaceutical’s Ameile Receives NMPA Review for Fifth Indication in NSCLC Treatment
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that its fifth indication filing...
CanSino Biologics’ Menhycia Vaccine Aims to Expand Age Range with NMPA Filing
CanSino Biologics (HKG: 6185) has announced that the National Medical Products Administration (NMPA) has accepted...
J&J’s Stelara Faces New Biosimilar Competition in China with CSPC Pharmaceutical’s Entry
Johnson & Johnson (J&J, NYSE: JNJ)’s auto-immune disease drug Stelara (ustekinumab) is set to encounter...
GSK’s Blenrep BLA for Multiple Myeloma Treatments Accepted by FDA for Review
UK-based pharmaceutical company GlaxoSmithKline (GSK; NYSE: GSK) has announced that the US Food and Drug...
J&J Submits sBLA to FDA for Subcutaneous Tremfya Regimen in Ulcerative Colitis
Johnson & Johnson (J&J; NYSE: JNJ) has submitted a supplemental Biologics License Application (sBLA) to...
Sciwind Biosciences’ Ecnoglutide Accepted for Review by China’s NMPA for Type 2 Diabetes
China-based Sciwind Biosciences Co., Ltd has announced that the National Medical Products Administration (NMPA) has...
Sino Biopharmaceutical Submits NDA for Anlotinib and Penpulimab Combo in HCC to NMPA
China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced the submission of a New Drug Application...
Beijing Balance Medical Technology’s ePTFE Implant Accepted for NMPA Review
Beijing Balance Medical Technology Co., Ltd (SHA: 688198) has announced that the National Medical Products...
Sunshine Guojian Pharmaceutical’s SSGJ-608 Files for NMPA Approval in Plaque Psoriasis
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, (SHA: 688336) a subsidiary of 3SBio Inc. (HKG: 1530),...
Sanofi’s Dupixent sBLA for Chronic Spontaneous Urticaria Accepted by FDA for Review
French pharmaceutical giant Sanofi has announced that the US Food and Drug Administration (FDA) has...
Sanofi’s Sarclisa Receives CHMP Recommendation for Newly Diagnosed Multiple Myeloma
French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that the Committee for Medicinal Products for...
Eisai and Biogen’s Lecanemab Receives Positive CHMP Opinion for Early Alzheimer’s Treatment
Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced that the...
Novartis’ Pluvicto Accepted for Review by China’s NMPA for Prostate Cancer Treatment
The Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has accepted...
Daiichi Sankyo and AstraZeneca File BLA for Datopotamab Deruxtecan in NSCLC
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN), partners in the development of innovative...
J&J Submits Regulatory Filings for Darzalex Faspro and Subcutaneous Daratumumab
Johnson & Johnson (J&J, NYSE: JNJ) has announced the submission of regulatory filings for its...
Dizal Pharmaceutical Submits NDA to FDA for Sunvozertinib as NSCLC Therapy
Dizal Pharmaceutical Co., Ltd (SHA: 688192), a Chinese pharmaceutical company, has announced the submission of...
AIM Vaccine Submits Market Filing for 13-Valent Pneumococcal Conjugate Vaccine in China
China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the submission of a market filing...
Eisai and Biogen Complete BLA Submission for Alzheimer’s Drug Leqembi to FDA
Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced the completion...
Sichuan Kelun-Biotech’s Sacituzumab Tirumotecan Files for New Indication with China’s NMPA
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that the National Medical Products Administration...