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)...
Drug
Pfizer’s Litfulo Earns EU Approval as First Treatment for Severe Alopecia Areata in Teens
Pfizer (NYSE: PFE) has been granted registration authorization by the European Commission (EC) for Litfulo...
Walvax Biotechnology Receives Indonesian FDA Approval for Phase III Pneumococcal Vaccine Trial
China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced that it has received approval from...
Sunshine Guojian Pharmaceutical Gets NMPA Approval for SSGJ-611 Phase II COPD Study
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, (SHA: 688336) a subsidiary of 3SBio Inc. (HKG: 1530),...
AbbVie’s Allergan Aesthetics Secures NMPA Approval for Juvéderm VOLUMA with Lidocaine
Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced that it has received marketing...
Caliway Biopharmaceuticals’ CBL-514 Achieves Milestones in Dercum’s Disease Trial
Taiwan-based Caliway Biopharmaceuticals, a specialist in medical aesthetics and inflammatory medicine, has announced that its...
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...
CSBIO’s Albenatide Shows Positive Results in Two Phase III Diabetes Trials
Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255) has announced encouraging results from two...
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)...
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...
CSPC Pharmaceutical Group Receives NMPA Approval for Irinotecan Liposome Injection
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received market approval...
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...
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...