NMPA Approves Sinocelltech’s Finotonlimab for Head and Neck Cancer
The National Medical Products Administration (NMPA) of China has approved Sinocelltech Group Ltd’s (SHA: 688520)...
Product approvals
Nuance Pharma’s Ohtuvayre Receives Regulatory Approval in Macau for COPD Treatment
China-based Nuance Pharma announced that it has received regulatory approval in Macau for its Ohtuvayre...
Sichuan Kelun-Biotech’s Datailai Gains NMPA Approval for Colorectal Cancer Treatment
China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that it has received marketing approval...
Keymed Biosciences’ Kangyueda Gains NMPA Approval for Seasonal Allergic Rhinitis
China-based Keymed Biosciences Inc. (HKG: 2162) announced that it has received another indication approval from...
AbbVie’s Emblaveo Wins FDA Approval for Complicated Intra-Abdominal Infections
US-based pharmaceutical giant AbbVie (NYSE: ABBV) announced that it has received marketing approval from the...
Sino Biopharmaceutical’s Tulobuterol Patch Gains NMPA Approval
China-based Sino Biopharmaceutical Ltd (HKG: 1177) announced that its subsidiary Beijing Tide Pharmaceutical Co., Ltd...
Roche’s Susvimo Approved by FDA for Diabetic Macular Edema
Swiss pharmaceutical giant Roche (SWX: ROG) announced that it has received approval from the US...
FDA Approves Enhertu for HER2-Low and HER2-UltraLow Breast Cancer
The US Food and Drug Administration (FDA) has approved Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody...
Sino Medical Sciences’ NC Rockstar Catheter Gains MDA Approval in Malaysia
China-based Sino Medical Sciences Technology Inc. (SHA: 688108) announced that it has received marketing approval...
Enhertu Approved by FDA for HR-Positive, HER2-Low Breast Cancer
Daiichi Sankyo (TYO: 4568) and AstraZeneca (AZ, NASDAQ: AZN) jointly announced that their co-developed antibody-drug...
MicroPort’s Fireliums Receives NMPA Approval for Coronary Bifurcation Stenosis Treatment
Shanghai-based medical device giant MicroPort Scientific Corp. (HKG: 0853) has announced receiving marketing approval from...
MicroPort’s TomaHawk Intravascular Shock Wave Therapy Device Approved by NMPA
Shanghai-based medical device giant MicroPort Scientific Corp. (HKG: 0853) has announced receiving marketing approval from...
FDA Clears sBLA for Eisai and Biogen’s Leqembi Maintenance Dosing
Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that the...
Guangzhou Innogen’s Efsubaglutide Alfa Approved by NMPA for Type 2 Diabetes
China-based Guangzhou Innogen Pharmaceutical Group Co., Ltd, a biopharma focused on metabolic diseases, has announced...
Roche’s cobas liat STI Assay Panels Gain FDA Approval and CLIA Waiver
Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced receiving approval from the US...
Sanofi’s Sarclisa Approved in EU for Newly Diagnosed Multiple Myeloma
France-based Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving marketing approval in the European Union...
Johnson & Johnson’s Spravato Approved as Monotherapy for Major Depressive Disorder
US-based Johnson & Johnson (J&J; NYSE: JNJ) has announced that its Spravato (esketamine) CIII nasal...
Kehua Bioengineering Gains NMPA Approval for Gene Polymorphism Detection Kits
China-based Shanghai Kehua Bioengineering Co., Ltd (SHE: 002022) has announced receiving marketing approvals from the...
Acotec’s Vericor-S2 Coronary Microcatheter Approved by NMPA
Acotec Scientific Holdings Ltd (HKG: 6669) has announced that its Vericor-S2 coronary microcatheter has received...
NMPA Approves Synaptic Medical’s Cryoablation Device and Gene Methylation Detection Kit
China’s National Medical Products Administration (NMPA) has granted marketing approval for two new medical devices:...