China’s NMPA Accepts EOC Pharma Group’s Filing for Vascepa (Icosapent Ethyl) for Review
The China-based EOC Pharma Group has achieved a significant milestone with the National Medical Products...
Market approval filings
Huadong Medicine’s Arcalyst (Rilonacept) Filing for CAPSs Accepted by China’s NMPA
Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that the National...
Jiangsu Hengrui Pharmaceuticals’ HR20031 Accepted for Review by China’s NMPA for Type 2 Diabetes
Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading Chinese pharmaceutical company, has announced that the National...
Clover Biopharmaceuticals Submits Market Filing for Seasonal Influenza Vaccine in Brazil
China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) has announced the submission of a market filing for...
Huadong Medicine’s Elahere Accepted for NMPA Review in China for Ovarian Cancer Treatment
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration...
BeiGene Submits Supplementary BLA for Tislelizumab in Small Cell Lung Cancer
BeiGene (NASDAQ: BGNE) has announced that its supplementary Biologic License Application (sBLA) for the programmed...
CANbridge’s Maralixibat Receives Priority Review for PFIC Treatment in China
China-based rare disease specialist CANbridge Pharmaceuticals Inc. (HKG: 1228) has announced that a New Drug...
AstraZeneca Seeks Approval for Capivasertib in Combination with Faslodex for Breast Cancer Treatment
AstraZeneca (AZ, NASDAQ: AZN) has submitted a market approval filing for its Category 1 drug...
Luye Pharma Files NDA for Paliperidone Palmitate Injectable Suspension with US FDA
China-based Luye Pharma Group (HKG: 2186) has announced the submission of a New Drug Application...
HutchMed and Takeda Submit Fruquintinib NDA for Metastatic CRC in Japan
China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced that its partner Takeda (TYO: 4502) has...
Coherus Biosciences Awaits FDA Decision on Toripalimab with Year-End Approval Forecast
Coherus Biosciences Inc., (NASDAQ: CHRS), a US-based biotechnology company, has provided an update on the...
Cutia Therapeutics Files for Market Approval of CU-10201 with NMPA for Acne Treatment
Cutia Therapeutics (HKG: 2487), a developer focused on dermatology therapies, has announced the submission of...
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)...
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...
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...
Haisco Pharmaceutical’s HSK16149 for Post-Herpes Neuralgia Accepted for NMPA Review
China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that the National Medical Products...
FDA Accepts Takeda’s Filing for Subcutaneous Entyvio as Maintenance Therapy for Crohn’s Disease
The US Food and Drug Administration (FDA) has accepted a filing from Japan-based Takeda (TYO:...
Huadong Medicine’s Subsidiary Viora Ltd’s V20 Accepted for NMPA Review
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that the National Medical Products Administration...
Sichuan Kelun Pharmaceutical Submits Biosimilar Cetuximab for NMPA Approval
Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), through its innovative drug development subsidiary Sichuan Kelun-Biotech...
EMA Reviews Janssen’s Balversa for Advanced Urothelial Carcinoma with FGFR3 Alterations
The European Medicines Agency (EMA) has accepted for review a filing made by the Janssen...