Astellas Pharma’s Vyloy Receives FDA Approval for CLDN18.2 Positive Gastric Cancer Treatment
Astellas Pharma (TYO: 4503) has announced that the U.S. Food and Drug Administration (FDA) has...
Product approvals
MicroPort CardioFlow’s Heart Valve Balloon Dilatation Catheter Alwide Plus Gains Mexican Approval
MicroPort Scientific Corp., a leading Chinese medical device company (HKG: 0853), through its spin-off MicroPort...
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...
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...
Novocure’s Optune Lua Wins FDA Approval for mNSCLC Treatment in Combination with Immunotherapies
Novocure (NASDAQ: NVCR), a Swiss firm renowned for its pioneering Tumor Treating Fields (TTFields) cancer...
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...
Lepu Medical Receives Approval for Noninvasive Blood Glucose Meter NeoGlu 01 in China
Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading provider of cardiovascular disease solutions...
Roche’s Vabysmo Receives NMPA Approval for Macular Edema Treatments in China
Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced the receipt of another marketing approval...
Intas Pharmaceuticals Receives FDA Approval for Biosimilar Stelara, Expanding Treatment Options for Autoimmune Diseases
Intas Pharmaceuticals Ltd, an Indian pharmaceutical company and partner of China’s Shanghai Henlius Biotech Inc....
AstraZeneca and Daiichi Sankyo’s Enhertu Receives Fourth Indication Approval in China
AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568)’s co-developed antibody drug conjugate (ADC), Enhertu (trastuzumab...
BMS’s Dual Immunotherapy Achieves Global First Approval for MSI-H/dMMR CRC in China
On October 14, 2024, Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the National Medical Products...
Junshi Biosciences’ Ongericimab Wins NMPA Nod for Hypercholesterolemia Treatment
Junshi Biosciences (HKG: 1877; SHA: 688180), a leading biopharmaceutical company in China, has announced that...
Pfizer’s Hympavzi Secures FDA Nod, Offering Novel Once-Weekly Treatment for Hemophilia B
Pfizer Inc. (NYSE: PFE) has scored a significant win with the US Food and Drug...
Roche’s Genentech Scores FDA Approval for Itovebi in Advanced Breast Cancer Treatment, Advancing Personalized Oncology
Roche (SWX: ROG)’s Genentech, a leader in pharmaceutical innovation, has received approval from the US...
Jiangsu Hengrui Secures FDA Nod for Generic Abraxane, Strengthening Oncology Portfolio
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has achieved a first in the US market...
Roche’s VENTANA CLDN18 Assay Receives EU Approval, Enhances Targeted Therapy Options for Gastric Cancer
Roche (SWX: ROG; OTCMKTS: RHHBY) has secured CE Mark approval in the European Union for...
Sunvozertinib’s Companion Diagnostic Gets NMPA Nod, Fortifying Targeted Therapy Arsenal for NSCLC in China
Dizal Pharmaceutical Co., Ltd (SHA: 688192) and Burning Rock Ltd (NASDAQ: BNR, FRA: 6BU0) have...