Roche’s Phesgo and Faricimab Receive NMPA Approvals for Breast Cancer and nAM
The National Medical Products Administration (NMPA) has granted separate approvals for two distinct drugs from...
Product approvals
BeiGene’s Tislelizumab Secures 12th Indication Approval in China for HCC First-Line Treatment
BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has received approval...
Gilead’s Kite Receives FDA Nod to Add Overall Survival Data to Yescarta for Large B-Cell Lymphoma
Gilead Sciences Inc. (NASDAQ: GILD) subsidiary Kite has received approval from the U.S. Food and...
Sino Medical Secures Approvals for Key Coronary Devices in Taiwan, India, and Uzbekistan
Sino Medical Sciences Technology Inc. (SHA: 688108), a China-based medical device company, has announced that...
Shanghai Henlius Secures Indonesian Approval for HanSiZhuang in Small-Cell Lung Cancer
Shanghai Henlius Biotech Inc. (HKG: 2696) has received market approval from the Indonesian Food and...
Cryofocus Medtech Secures NMPA Approval for Cryotherapy Equipmen
Shanghai-based Cryofocus Medtech (Shanghai) Co., Ltd. (HKG: 6922) has announced that it has received marketing...
NMPA Approves Pulnovo Medical’s Novel Catheter for Treating Pulmonary Arterial Hypertension
The National Medical Products Administration (NMPA) has granted marketing approval for Pulnovo Medical’s disposable circular...
Sanofi Gains NMPA Approval for Innovative Rosuvastatin and Ezetimibe Combination Therapy
Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has announced that it has received market approval...
AstraZeneca Secures FDA Approval for Self-Administered hATTR-PN Therapy Wainua
AstraZeneca (AZ, NASDAQ: AZN), headquartered in the UK, announced last week that the U.S. Food...
Takeda’s Livtencity Receives NMPA Approval, a First in China for CMV Infection Treatment
Japanese pharmaceutical company Takeda (TYO: 4502) has received its first market approval from China’s National...
Beijing Balance Medical Secures NMPA Approval for Innovative Mitral Valve Annuloplasty Ring
Beijing Balance Medical Technology Co., Ltd (SHA: 688198), a Chinese medical device company, has received...
Lee’s Pharmaceutical’s Socazolimab Becomes China’s First PD-L1 mAb for Cervical Cancer
Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has secured in-licensed rights for socazolimab, a treatment for...
FDA Rejects MSD’s Gefapixant for Chronic Cough Treatment Over Efficacy Concerns
The US Food and Drug Administration (FDA) has declined to approve a filing from Merck,...
European Commission Expands Keytruda Indications for Advanced Cancer Treatments
The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) additional indications...
EMA’s CHMP Gives Green Light to Sanofi’s Fexinidazole for Acute Sleeping Sickness Treatment
Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...
BGI Genomics Receives NMPA Approval for Innovative Colorectal Cancer Detection Kit
BGI Genomics Co., Ltd. (SHE: 300676), a leading genomics firm based in China, has announced...
Keytruda Gains 12th Indication Approval in China for HER2-Negative Gastric Cancer
US pharmaceutical giant Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its immunotherapy...
Roche Receives NMPA Approval for Ophthalmology BsAb Vabysmo (Farcimab) for Diabetic Macular Edema
Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has obtained marketing approval from...
FDA Approves Pfizer-Astellas-MSD Combo Therapy for Advanced Urothelial Cancer
Pfizer (NYSE: PFE), Astellas (TYO: 4503), and Merck, Sharp & Dohme (MSD; NYSE: MRK) have...
Sanofi’s Rezurock Secures Marketing Approval in China for Chronic Graft-vs-Host Disease
French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that its drug Rezurock (belumosudil), the world’s...