AstraZeneca’s Enhertu Receives Priority Review for Expanded HER2-positive Solid Tumor Indication
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) has announced that an indication extension filing for...
Market approval filings
Johnson & Johnson’s Rybrevant and Lazertinib Filings Accepted for Review by CDE
The Center for Drug Evaluation (CDE) has confirmed that Johnson & Johnson’s (J&J, NYSE: JNJ)...
Eisai’s Uric Acid Excretion Drug Urece Accepted for Review in China
The Center for Drug Evaluation (CDE) in China has indicated on its website that it...
BeiGene Submits Additional Application for Tislelizumab in NSCLC in China
BeiGene (NASDAQ: BGNE) has announced the submission of a supplementary Biologic License Application in China...
SciClone’s Partner Menarini Files for Elacestrant Approval in Macau for Advanced Breast Cancer
SciClone Pharmaceuticals Inc. (HKG: 6600) has announced that its Italian partner, Menarini Group, has submitted...
Huadong Medicine’s Relmapirazin Approval Filing Accepted by NMPA for GFR Measurement
Huadong Medicine Co., Ltd (SHE: 000963), based in China, has announced that its market approval...
Eisai’s Lemborexant Sleep Aid Lemborexant Filed for NMPA Approval in China
The China Center for Drug Evaluation (CDE) website has indicated that Japan-based Eisai (TYO: 4523)...
Astellas’ Zolbetuximab Faces FDA Rejection Due to Manufacturing Facility Deficiencies
The US Food and Drug Administration (FDA) has issued a rejection for a filing submitted...
Genrix Bio Seeks China Approval for New Xeligekimab Use in Axial Spondyloarthritis
Chongqing Genrix Biopharmaceutical Co., Ltd. (SHA: 688443), a biopharmaceutical company based in China, has submitted...
Akeso Biopharma Submits New Indication Application for Cadonilimab in Gastric Cancer Treatment
Akeso Biopharma (HKG: 9926), a leading biopharmaceutical company based in China, has announced the submission...
JW Therapeutics Secures NMPA Review for CAR-T Therapy in Mantle Cell Lymphoma
JW Therapeutics (HKG: 2126), a Chinese biopharmaceutical company, has announced that it has submitted an...
Jiangsu Vcare PharmaTech Submits NDA to US FDA for Vicagrel, a P2Y12 Receptor Antagonist
Jiangsu Vcare PharmaTech Co., Ltd, a Chinese pharmaceutical company, has submitted a New Drug Application...
InventisBio’s KRAS G12C Inhibitor Garsorasib NDA Accepted for Review by China’s NMPA
InventisBio (Shanghai) Co., Ltd (SHA: 688382), a China-based pharmaceutical company, has announced that the New...
BMS’ Augtyro Receives EMA Review for Advanced Lung Cancer and Solid Tumors Treatments
The European Medicines Agency (EMA) has accepted for review a filing submitted by Bristol Myers...
FDA Prioritizes Roche’s Xolair for Food Allergy Indication Extension Ahead of Q1 Decision
The U.S. Food and Drug Administration (FDA) has prioritized Roche’s (SWX: ROG) indication extension filing...
Taiwan FDA Reviews Nefecon New Drug Application from Everest Medicines
China-based Everest Medicines (HKG: 1952) has announced that the New Drug Application (NDA) for Nefecon...
Amgen’s Lumakras Faces Full Approval Delay as FDA Requests New Study
The US Food and Drug Administration (FDA) has declined to grant full approval for Amgen’s...
Guangdong Zhongsheng Pharmaceutical’s ZSP1273 for Influenza A Accepted for Review by NMPA
Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a Chinese pharmaceutical company, has announced that China’s...
FDA Grants Priority Review to MSD and Daiichi Sankyo’s ADC for Lung Cancer
The US Food and Drug Administration (FDA) has accepted under priority review a filing from...
J&J’s Rybrevant-Lazertinib Combo Accepted for FDA Review in NSCLC
The US Food and Drug Administration (FDA) has accepted for review Johnson & Johnson’s (J&J;...