FDA Extends Review of Amgen’s Lumakras for KRAS G12C mCRC Treatment to January 2025
On October 18, FirstWord reported that the U.S. FDA has extended the review period for...
Drug
Shenzhen Chipscreen Advances CS231295 for Cancer Treatment as IND Accepted by NMPA
On October 17, Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced that its innovative Class...
AstraZeneca Files for Market Approval of Tremelimumab in China for Hepatocellular Carcinoma
The Center for Drug Evaluation (CDE) has indicated on its website that AstraZeneca (NASDAQ: AZN),...
Changshan Biochemical Pharmaceutical Wins Marketing Approval for Enoxaparin in Niger
Hebei Changshan Biochemical Pharmaceutical Co., Ltd (CSBIO; SHE: 300255), a Chinese pharmaceutical company, has announced...
Huahai Pharmaceutical Gets FDA Nod for Generic Empagliflozin and Metformin ANDA
Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a prominent Chinese pharmaceutical company, has announced the...
Laekna Advances Obesity Treatment Candidate LAE102 with Subcutaneous Dosing in Phase I Study
Laekna, a Sino-US biotech firm, has announced the commencement of a subcutaneous dosing cohort within...
Antengene’s Xpovio Secures Expanded Access in South Korea for Multiple Myeloma Treatment
Antengene Corp., Ltd (HKG: 6996), a China-based biopharmaceutical company, has announced that it has received...
AbbVie’s Vyalev Wins FDA Approval as First Subcutaneous Levodopa Therapy for Advanced Parkinson’s
AbbVie (NYSE: ABBV), a leading pharmaceutical company based in the US, has received approval from...
Chongqing Zhifei Biological’s EC Injection Receives Market Approval in Indonesia
Chongqing Zhifei Biological Co., Ltd (SHE: 300122), a leading biopharmaceutical company based in China, has...
Kintor Pharmaceutical Initiates Phase II/III Trial for KX-826 Tincture 1.0% in Treating Male Androgenetic Alopecia
Kintor Pharmaceutical Ltd (HKG: 9939), a biopharmaceutical company based in China, has announced the commencement...
Innovent Biologics’ Picankibart Achieves Positive Results in Phase II UC Study
Innovent Biologics, Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that...
Johnson & Johnson’s Nipocalimab Shows Promise in Treating Adolescent Myasthenia Gravis in Phase II/III Trial
Johnson & Johnson (J&J, NYSE: JNJ), a US pharmaceutical giant, has reported encouraging outcomes from...
Alphamab Oncology and CSPC Pharma’s KN026 Phase III Trial for Breast Cancer Gets NMPA Approval
Alphamab Oncology (HKG: 9966) and CSPC Pharma (HKG: 1093) have jointly announced that their Phase...
Shanghai Junshi Biosciences’ Toripalimab Wins Marketing Approvals in India and Hong Kong for Nasopharyngeal Carcinoma
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biotech company based in...
Jiangsu Hengrui Resubmits Application for Camrelizumab Combo in HCC to FDA
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent pharmaceutical company based in China, has...
Innovec Biotherapeutics’ IVB103 Gene Therapy for nAMD Receives Clinical Trial Approval from China’s CDE
Beijing InnoVec Biotherapeutics Inc., a leading gene therapy company based in China, has announced that...
Aficamten Market Filing Accepted by China’s CDE for Hypertrophic Cardiomyopathy Treatment
CORXEL, formerly known as Ji Xing Pharmaceuticals and Cytokinetics Inc (CYTK, NASDAQ: CYTK) have achieved...
Jiangsu Hengrui’s Hetrombopag Olamine Receives NMPA Review for Severe Aplastic Anemia Indication
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has...
Hinova Pharmaceuticals Gets NMPA Green Light for HP568 Clinical Study in Breast Cancer
Hinova Pharmaceuticals Inc. (SHA: 688302), a biotech firm based in Chengdu, has announced that it...
Huadong Medicine Gets NMPA Green Light for BCMA-Targeted ADC HDM2027 Phase I/IIa Study
Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has...