Innovent Biologics’ Ipilimumab NDA Accepted by CDE with Priority Review for Colon Cancer
China-based Innovent Biologics, Inc. (HKG: 1801) announced that the Center for Drug Evaluation (CDE), National...
Market approval filings
GSK’s Nucala Receives NMPA Review for COPD Treatment
GSK plc (LON: GSK, NYSE: GSK) announced that the National Medical Products Administration (NMPA) has...
Huadong Medicine’s Biosimilar Tresiba Accepted by NMPA for Review
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market filing for a biosimilar...
Boehringer Ingelheim’s Zongertinib NDA Accepted by FDA for HER2-Mutated NSCLC
Germany-based Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has accepted its...
Gilead Sciences’ Lenacapavir NDA for HIV Prevention Accepted by FDA for Priority Review
US-based Gilead Sciences Inc. (NASDAQ: GILD) announced that the New Drug Application (NDA) for its...
Hengrui Pharma’s HR19034 Eye Drops for Myopia Delay Accepted by NMPA
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that its market filing for HR19034 eye...
IASO Bio’s Fucaso NDA Accepted by Hong Kong DOH for Relapsed/Refractory Multiple Myeloma
China-based IASO Bio announced that a New Drug Application (NDA) for its BCMA-targeted chimeric antigen...
Hengrui Pharma Submits Ivarmacitinib Ointment for AD Treatment Approval
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced the submission of a marketing filing for...
Huadong Medicine’s Biosimilar SaiYueXin Seeks NMPA Approval for Crohn’s Disease
Huadong Medicine Co., Ltd (SHE: 000963) announced that another indication approval filing for its SaiYueXin,...
Bayer Files for Eylea 8 mg EMA Approval to Extend AMD, DME Treatment Intervals
Bayer (ETR: BAYN) has submitted a marketing application to the European Medicines Agency (EMA) for...
Beijing Luzhu Submits BLA for LZ901 Herpes Zoster Vaccine to NMPA
Beijing Luzhu Biotechnology Co., Ltd (HKG: 2480), a human vaccine and therapeutic biologics manufacturer, announced...
Hansoh Pharma’s Uplizna Receives Priority Review for IgG4-RD Treatment
Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that the National Medical Products Administration (NMPA)...
Bio-Thera’s Biosimilars BAT2306 and BAT2506 Accepted for Review by NMPA and EMA
China-based Bio-Thera Solutions Inc. (SHA: 688177) announced that the market filings for its biosimilars BAT2306...
CanSino’s Tetanus Vaccine NDA Accepted for Review by NMPA
China-based vaccines specialist CanSino Biotechnology Inc. (HKG: 6185) announced that the National Medical Products Administration...
EMA Committee Backs Subcutaneous Rybrevant for Lung Cancer Treatment
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
Bayer Files for EMA Approval of Kerendia for Heart Failure
Bayer AG (FRA: BAYN) announced that it has made another market filing with the European...
Astellas Pharma Submits NDA for Avacincaptad Pegol in Japan for Geographic Atrophy
Japan-based major Astellas Pharma (TYO: 4503) announced that it has submitted a New Drug Application...
IASO Bio’s CAR-T Therapy Fucaso Accepted for Review in Singapore
China-based IASO Biotherapeutics has announced that a New Drug Application (NDA) for its BCMA-targeted chimeric...
Huadong Medicine’s Ellansé M Filing Accepted by China’s NMPA
China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that its market filing for the...
Hengrui’s Long-Acting Insulin Analogue Accepted for Review by China’s NMPA
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that its market filing for...