European Commission Approves Takeda’s Hyqvia for Chronic Inflammatory Demyelinating Polyneuropathy
The European Commission (EC) has granted regulatory approval to Takeda Pharmaceutical Company Limited (TYO: 4502)...
Product approvals
Hengrui Pharmaceuticals Scores First-Mover Status with FDA Approval for Generic Astagraf XL
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has...
Takeda’s Gammagard Liquid Approved by FDA for Chronic Inflammatory Demyelinating Polyneuropathy
The US Food and Drug Administration (FDA) has granted regulatory approval for Takeda’s (TYO: 4502)...
EMA’s CHMP Endorses Bristol Myers Squibb’s CAR-T Therapy Abecma for Multiple Myeloma
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
Dupixent by Sanofi and Regeneron Approved by FDA for Eosinophilic Esophagitis in Younger Pediatric Patients
The US Food and Drug Administration (FDA) has concluded a priority review and granted approval...
Eisai’s Alzheimer’s Drug Leqembi Earns Marketing Approval in China
Eisai (TYO: 4523), a leading Japanese pharmaceutical company, has announced that it has received marketing...
Gan & Lee Pharmaceuticals Receives Bolivian Approval for Insulin Aspart, Expanding Access to Rapid-Acting Insulin
Gan & Lee Pharmaceuticals (SHA: 603087), a Chinese pharmaceutical company, has announced that it has...
Pfizer’s Nurtec Approved by China’s NMPA for Acute Treatment of Migraines
Pfizer Inc. (NYSE: PFE), a leading pharmaceutical company in the U.S., has announced that it...
Novo Nordisk’s Rybelsus Approved for Type 2 Diabetes in China, Setting New Oral Treatment Standard
Novo Nordisk (NYSE: NVO), a major Danish pharmaceutical company, has received approval from China’s National...
Zylox-Tonbridge Medical Technology Secures NMPA Nod for Innovative Iliac Vein Stent System
Zylox-Tonbridge Medical Technology (HKG: 2190), a leading developer of nerve and peripheral vascular interventional devices...
Jiangsu Wuzhong Pharmaceutical’s Aesthetics Subsidiary Wins Approval for Facial Filler in China
Jiangsu Wuzhong Pharmaceutical Group Corp., (SHA: 600200), a prominent player in the Chinese pharmaceutical industry,...
Lepu Medical Technology Gains NMPA Approval for Innovative Coronary Device
Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading Chinese provider of cardiovascular disease...
AstraZeneca Wins FDA Nod for Airsupra in Asthma Treatment
AstraZeneca (AZ; NASDAQ: AZN), a leading UK pharmaceutical company, announced this week that it has...
NMPA Grants Marketing Approval for Hui Sheng Bio-pharmaceutical’s Janagliflozin
The National Medical Products Administration (NMPA) has granted marketing approval for Hui Sheng Bio-pharmaceutical Co.,...
J&J’s Balversa Receives Full FDA Approval for Urothelial Carcinoma Treatment
The US Food and Drug Administration (FDA) has converted the 2019 accelerated approval for Johnson...
Uni-Bio Science Group Wins NMPA Nod for Generic Forteo Injection for Osteoporosis
Hong Kong-listed biopharmaceutical company Uni-Bio Science Group Ltd (HKG: 0690) has announced that it has...
Sichuan Kelun-Biotech Secures NMPA Nod for Generic Lynparza Equivalent
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a Chinese pharmaceutical company, has announced that it...
Sanofi’s Dupixent Receives FDA Label Update for Atopic Dermatitis Patients with Hand or Foot Involvement
Sanofi (NASDAQ: SNY) has been granted authorization by the US Food and Drug Administration (FDA)...
Ultrasound Biotechnology Earns FDA Nod for Disposable Endoscopic Ultrasound Probes
Ultrasound Biotechnology, the Shanghai-based wholly owned subsidiary of US firm Ultrasound Wondering, Inc., has announced...
FDA Approves Casgevy, the First CRISPR-Based Gene Editing Therapy for β-Thalassemia
Casgevy (exagamglogene autotemcel), the pioneering gene editing therapy based on CRISPR technology, has received approval...