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,...
Product approvals
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)...
MSD’s Keytruda Gains EC Approval for First-Line HER2-Positive Gastric Cancer Treatment
The European Commission (EC) has granted an additional indication to Merck, Sharp & Dohme (MSD;...
BMS’ Reblozyl Expands Indication to Include First-Line MDS-Related Anemia Treatment
Bristol-Myers Squibb (BMS; NYSE: BMY) has received an indication extension approval from the US Food...
Zhejiang Huahai Pharmaceutical Receives FDA Approval for Generic Vyvanse
Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced the receipt...
Sandoz Receives FDA Clearance for First Biosimilar to Biogen’s Tysabri
The Sandoz unit of Switzerland-based Novartis (NYSE: NVS) has received regulatory clearance from the US...
Pfizer’s RSV Vaccine Abrysvo Receives European Commission Approval for Maternal Immunization
Pfizer (NYSE: PFE) has received registration approval from the European Commission (EC) for its respiratory...
FDA Approves Gilead’s Veklury for COVID-19 Treatment in Patients with Hepatic Impairment
The US Food and Drug Administration (FDA) has approved a new indication for Gilead’s (NASDAQ:...
AstraZeneca and MSD’s Lynparza Gets Green Light for Prostate Cancer Treatment in Japan
Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted AstraZeneca (AZ; NASDAQ: AZN) and...
Microport EP Medtech’s Cryoablation Catheter and Equipment Approved as Innovative Devices in China
Shanghai Microport EP Medtech Co., Ltd has announced that its balloon type cryoablation catheter and...
CSPC Pharmaceutical’s Generic Entresto Approved in China for Heart Failure Treatment
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its generic version of Swiss...
Dizal Pharmaceutical’s Sunvozertinib Approved by China’s NMPA for NSCLC Treatment
China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that it has received market approval...
Nanjing F&S Pharmatech Secures First Generic Approval for Novartis’s Entresto in China
Nanjing F&S Pharmatech Co., Ltd, a China-based pharmaceutical company, has announced that it has received...
European Commission Grants Conditional Approval for Janssen’s Talvey in Multiple Myeloma
The European Commission (EC) has granted conditional approval to Johnson & Johnson’s (J&J; NYSE: JNJ)...
Novartis’s Leqvio (Inclisiran) Approved in China for Hypercholesterolemia Treatment
Swiss pharmaceutical giant Novartis (NYSE: NVS) has received approval from the National Medical Products Administration...
Sichuan Huiyu Pharmaceutical’s Plerixafor Gains Marketing Approval from Italian Medicines Agency
Sichuan Huiyu Pharmaceutical Co., Ltd (SHA: 688553), a China-based pharmaceutical company, has announced that it...
Lifetech Scientific Corporation Receives NMPA Approval for Epione Navigation System
China-based Lifetech Scientific Corporation (HKG: 1302) has announced that it has received market approval from...
Pfizer’s RSV Vaccine Abrysvo Receives FDA Authorization for Maternal Immunization
The US Food and Drug Administration (FDA) has authorized the use of Pfizer’s (NYSE: PFE)...