Astellas Pharma’s Xtandi NDA for mHSPC Treatment Accepted by China’s CDE
Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the Center for Drug Evaluation (CDE)...
Cancer
Zhejiang Medicine Gets NMPA Approval for NCB003 Clinical Study for Advanced Solid Tumors
Zhejiang Medicine Co., Ltd (SHA: 600216), a China-based pharmaceutical company, has announced that it has...
Zelgen Biopharmaceuticals’ rhTSH Achieves Primary Endpoint in Phase III Study
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a China-based pharmaceutical company, has announced that its...
Sandoz Receives Positive CHMP Review for Trastuzumab Biosimilar in HER2-Positive Cancers
Sandoz (SWX: SDZ), the generic and biosimilar drug maker set to separate from Novartis (NYSE:...
Gilead’s Kite CAR-T Therapy Yescarta Achieves 71% CMR in Phase II Trial for R/R LBCL Patients
Gilead’s (NASDAQ: GILD) subsidiary Kite has announced early results from a Phase II trial of...
EMA’s CHMP Backs Enhertu for Advanced NSCLC with HER2 Mutations
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
BMS Expands Partnership with Samsung Biologics for Oncology Drug Manufacturing
Global pharmaceutical company Bristol-Myers Squibb (BMS; NYSE: BMY) has announced an expansion of its existing...
EMA’s CHMP Recommends Approval of Keytruda as Adjuvant NSCLC Treatment
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
Novartis’s Kisqali Reduces Cancer Recurrence Risk in HR+/HER2- Early Breast Cancer: Phase III Results
Swiss pharmaceutical giant Novartis (NYSE: NVS) has published results from a Phase III study of...
Akeso Biopharma’s AK132 Receives Green Light for Clinical Trial in Advanced Solid Tumors
Akeso Biopharma’s (HKG: 9926) AK132, a bispecific antibody (BsAb) targeting Claudin18.2 and CD47, has received...
Tuodao Medical’s Percutaneous Puncture Surgery Robot NP100 Approved in China
China-based surgical robot developer Tuodao Medical Technology Co., Ltd has received marketing approval for its...
Japan’s MHLW Reviews GSK’s Momelotinib for Myelofibrosis Treatment
The Ministry of Health, Labour and Welfare (MHLW) in Japan has accepted for review a...
AstraZeneca and Daiichi Sankyo Report Positive Results for Datopotamab Deruxtecan Combo in NSCLC
UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced positive data from a Phase Ib...
Sichuan Kelun Pharmaceutical Secures Exclusive Rights to TBM-001 for Bone Metastasis Diagnosis
Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), through its innovative drug development subsidiary Sichuan Kelun-Biotech...
Chongqing Lummy Pharmaceutical’s Subsidiary Receives NMPA Approval for CUD002 mRNA Vaccine
Chongqing Lummy Pharmaceutical Co., Ltd (SHE: 300006), through its subsidiary Sichuan Cunde Therapeutics Co., Ltd,...
Dizal Pharmaceutical’s Golidocitinib NDA Accepted for Review by NMPA
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that the National Medical Products Administration...
EMA Approves Astellas’ Xtandi for Non-Metastatic Hormone-Sensitive Prostate Cancer
The European Medicines Agency (EMA) has granted Japan-based Astellas (TYO: 4503) an indication extension approval...
Boehringer Ingelheim Gets NMPA Approval for Brigimadlin Safety and Efficacy Study in China
Germany-based Boehringer Ingelheim (BI) has announced that it has received approval from the National Medical...
AstraZeneca’s Tagrisso Combination Therapy Shows Improved Efficacy in EGFR-mutated NSCLC
UK-headquartered AstraZeneca (AZ; NASDAQ: AZN) has announced interim Phase III data demonstrating that the addition...
Janssen Reports Positive Results from Phase Ib/II Study of Rybrevant Combo in EGFR-mutated NSCLC
Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has provided an update on an ongoing...