Hainan Poly Pharm Submits DMF for Tecovirimat API to US FDA
China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced the filing of a Drug...
South Africa’s Competition Commission Investigates J&J for MDR-TB Drug Pricing and Evergreening
The Competition Commission of South Africa has announced an investigation into Johnson & Johnson (J&J;...
Tonghua Golden-Horse’s Octohydroaminoacridine Succinate Meets Phase III Endpoints in Alzheimer’s Disease
China-based Tonghua Golden-Horse Pharmaceutical Industry Co., Ltd. (SHE: 000766) has announced positive results from its...
China’s NHC Expands Rare Disease List, Includes 21 Cancer Types
The National Health Commission (NHC) of China has released an updated national list of rare...
AIM Vaccine’s Serum-Free Rabies Vaccine Completes Phase III Safety Observation
China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the successful completion of the 7-day...
Jiangsu Yahong’s Cevira Meets Primary Endpoint in Phase III Cervical HSIL Study
Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176), a specialist in urogenital cancer treatments, has...
Hybio Pharmaceutical Gets NMPA Approval for COVID-19 Nasal Spray HY3000
China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has received approval from the National Medical Products...
GSK’s Ojjaara Approved by FDA for Anemic Myelofibrosis Patients
The US Food and Drug Administration (FDA) has granted regulatory approval to GlaxoSmithKline (GSK; NYSE:...
BeiGene Regains Full Rights to Tislelizumab After Terminating Novartis Deal
China-based biotech company BeiGene (NASDAQ: BGNE) has reached a mutual agreement with Novartis (NYSE: NVS)...
Kinnate Biopharma Announces Restructuring and Job Cuts Amid Financial Pressures
US-based Kinnate Biopharma Inc., (NASDAQ: KNTE), a company dedicated to the development of small-molecule cancer...
Jiangsu Hengrui Pharmaceuticals Wins NMPA Approval for Two Novel Drug Candidates
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced receiving...
Pfizer’s Cibinqo and Everest Medicines’ Cefepime-Taniborbactam Selected for Priority Reviews by CDE
The Center for Drug Evaluation (CDE) has indicated on its website that Pfizer’s (NYSE: PFE)...
EMA’s CHMP Supports Gilead’s Veklury for COVID-19 Patients with Hepatic Impairment
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recently...
Eli Lilly Partners with Boundless Bio to Develop CHK1 Inhibitor for Solid Tumors
Eli Lilly (NYSE: LLY) has announced a partnership with precision oncology specialist Boundless Bio to...
NHSA Clears Retagliptin and Ambroxol for National Reimbursement Drug List Inclusion
The National Healthcare Security Administration (NHSA) has completed a review of the National Reimbursement Drug...
FDA Grants Priority Review to MSD’s Welireg for Advanced RCC Indication Extension
The US Food and Drug Administration (FDA) has granted priority review status to an indication...
Kangtai Biological Expands Global Reach with Varicella Vaccine Licensing Deals
Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601), a China-based biopharmaceutical company, has entered into...
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...