CSPC Pharmaceutical Group Receives NMPA Approval for Irinotecan Liposome Injection
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received market approval...
Product approvals
Genesis MedTech Receives Chinese Market Approval for Antibacterial Absorbable Sutures
Singapore-based medical device company Genesis MedTech has announced that it has received market approval in...
EMA Approves Astellas’ Xtandi for Non-Metastatic Hormone-Sensitive Prostate Cancer
The European Medicines Agency (EMA) has granted Japan-based Astellas (TYO: 4503) an indication extension approval...
Grand Pharmaceutical Receives NMPA Approval for Generic Carbaglu for Hyperammonemia Treatment
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that it has received marketing approval...
FDA Extends Pfizer’s Comirnaty Vaccine Indication for Omicron XBB.1.5 Variant
The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) an indication extension...
Lepu Medical Technology Receives NMPA Approval for MemoSorb Biodegradable PFO Occluder
China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has announced...
Merck’s Keytruda Approved in China for MSI-H/dMMR Advanced Solid Tumors: A Biomarker-Driven Milestone
US pharmaceutical major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its programmed...
Luye Pharma’s Botawei Receives NMPA Approval for Breast Cancer Treatment
Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the...
CSPC Pharmaceutical’s Narlumosbart Approved by NMPA for Bone Giant Cell Tumors
CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its subsidiary, Shanghai JMT Biotechnology Co.,...
Acotec Scientific Holdings Receives Marketing Approvals for Vericor-14 Microcatheter in Japan and Thailand
China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced that it has received marketing approvals...
Harbin Gloria Pharmaceuticals’ Zimberelimab Receives NMPA Approval for Cervical Cancer Treatment
China-based Harbin Gloria Pharmaceuticals Co., Ltd (SHE: 002437) has announced that it has received market...
Hansoh Pharmaceutical Receives NMPA Approval for Generic Ofev (Nintedanib)
China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that it has received marketing...
Chia Tai Tianqing’s Generic Entresto Approved by NMPA, Launch Expected in 2026
The National Medical Products Administration (NMPA) website has indicated that Chia Tai Tianqing’s generic version...
Bayer Subsidiary’s Parkinson’s Treatment Bemdaneprocel Shows Promise in Phase I
Germany-based Bayer (ETR: BAYN) has announced that its subsidiary BlueRock Therapeutics’ open-label Phase I study...
AstraZeneca’s Calquence Approved by NMPA for Chronic Lymphocytic Leukemia Treatment
UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received another indication...
Eli Lilly’s Verzenios Receives NMPA Approval for Extended Indication in Early-Stage Breast Cancer
US pharmaceutical major Eli Lilly & Co., (NYSE: LLY) has announced that the National Medical...
Zai Lab’s Margenza (Margetuximab) Approved by China’s NMPA for HER2-Positive Breast Cancer
The National Medical Products Administration (NMPA) website has indicated that Zai Lab Ltd’s (NASDAQ: ZLAB,...
AstraZeneca’s Soliris Gains Approval for Pediatric Generalized Myasthenia Gravis in Japan
UK pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received an...
Pfizer and BioNTech Receive Positive CHMP Opinion for Comirnaty Vaccine
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
Roche’s Evrysdi Receives EC Approval for Expanded Indication in Infants with SMA
Swiss pharmaceutical giant Roche (SWX: ROG) has received regulatory approval from the European Commission (EC)...