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...
Product approvals
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...
Sino Biopharmaceutical Receives NMPA Approval for Generic Revolade Equivalent
Sino Biopharmaceutical Ltd (HKG: 1177), a major player in the Chinese pharmaceutical industry, announced that...
Takeda’s Hyqvia Approved by FDA for Chronic Inflammatory Demyelinating Polyneuropathy
Japanese pharmaceutical company Takeda (TYO: 4502) has received an indication extension approval from the US...
Qilu Pharmaceutical’s Iruplinalkib Gains Additional Indication Approval in China for ALK-Positive NSCLC
The National Medical Products Administration (NMPA) website has indicated that Qilu Pharmaceutical’s Category 1 drug,...
Roche’s Tecentriq SC Receives European Nod as First Subcutaneous PD-(L)1 Therapy
Halozyme Therapeutics (NASDAQ: HALO) has announced that the European Commission (EC) has granted marketing authorization...