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)...
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...
Tianjin Century Kangtai Biomedical Raises Hundreds of Millions in Series A+ and B Financings
Tianjin Century Kangtai Biomedical Engineering Co., Ltd, a China-based company, has reportedly secured hundreds of...
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...
Northeast Pharmaceutical Partners with Muscat Changming for Middle East Expansion
China-based Northeast Pharmaceutical Co., Ltd (SHE: 000597) has entered into an investment framework agreement with...
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...
BRIM Biotechnology Raises $45.8 Million in Premium Share Issue for Pipeline Expansion
Taiwan-based BRIM Biotechnology, Inc. (TPEx 6885), a biotechnology company specializing in the development of regenerative...
Suzhou Acumen Biomedical Secures $13.8 Million in Series A+ Funding Round
China’s Suzhou Acumen Biomedical Technology Co., Ltd. has reportedly raised close to RMB 100 million...
MicroPort MedBot’s SkyWalker Robot Approved for Orthopedic Surgery by NMPA
Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that it has received marketing...
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...
China’s CDE Proposes Removal of Ambroxol Inhalation Solution and Four Other Drugs
The Center for Drug Evaluation has issued a notification concerning the Chemical Generic Drug Reference...
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:...
NMPA Drafts Quality Management Norms for Online Medical Device Sales
The National Medical Products Administration (NMPA) has issued the “Medical Device Online Sales Quality Management...
NMPA Seeks Comments on Medical Device Classification Draft Proposal
The National Medical Products Administration (NMPA) has issued a notification focusing on the definition and...
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...