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...
Product approvals
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...
Sino Medical Sciences Secures NMPA Nod for Balloon Guided Catheter to Aid Vascular Procedures
China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced that it has received marketing...
Biogen’s China Unit Gets Conditional NMPA Nod for Qalsody (Tofersen) in ALS Treatment
Biogen (NASDAQ: BIIB)’s Chinese subsidiary has announced that it has received conditional approval from the...
Joincare Pharmaceutical Secures NMPA Approval for Triptorelin Microspheres to Treat Endometriosis
China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) has announced that it has received...
CSPC Pharmaceutical Secures NMPA Approval for Omalizumab Biosimilar
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received marketing approval...
Jiangsu Aidea Pharmaceutical Secures NMPA Approval for Expanded Indication of Fubangde in HIV Treatment
China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that the National Medical Products...
MicroPort Endovascular MedTech’s Fiber Wool Plug Spring Coil Gains NMPA Marketing Approval
Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016) has received marketing approval from the National...
BMS Expands Opdivo Indication with FDA Approval for NSCLC Combo Therapy
The U.S. Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS,...
LenoMed Medical’s Touch-Insulin Pump Receives NMPA Approval, Aids China’s Diabetes Management
Shanghai-based LenoMed Medical, a medical device platform company backed by Legend Capital and Legend Star,...
Qilu Pharmaceutical’s QL1706 Receives NMPA Conditional Approval for Cervical Cancer Treatment
Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its combination drug QL1706, comprising iparomlimab...
AstraZeneca’s Tagrisso Secures FDA Approval for Unresectable Stage III EGFRm NSCLC
AstraZeneca (NASDAQ: AZN, LON: AZN), a UK-based pharmaceutical giant, has announced that it has received...
Sansure Biotech’s HPV Detection Kit Receives NMPA Approval for Comprehensive Screening
Sansure Biotech Inc., a molecular diagnostics specialist based in China and listed on the Shanghai...
Sino Biopharmaceutical Receives NMPA Approval for Rivastigmine Patch for Mild-to-Moderate Alzheimer’s
Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced that...