Chongqing Genrix Biopharmaceutical Receives NMPA Approval for Xeligekimab, First Domestic Anti-IL-17 Antibody
Chongqing Genrix Biopharmaceutical Co., Ltd, a Chinese biopharmaceutical company, has received marketing approval from China’s...
Product approvals
Regeneron Secures EU Approval for Ordspono, Its First Bispecific Antibody
Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) has secured its first global market approval for Ordspono (odronextamab)...
Chinese NMPA Grants License to MicroPort Endovascular MedTech’s Venous Stent for Treating Vascular Conditions
Shanghai MicroPort Endovascular MedTech Co., Ltd, a Chinese endovascular device manufacturer listed on the Shanghai...
Henlius Biotech’s Biosimilar Herceptin Approved by Health Canada for Breast and Gastric Cancer Treatments
Shanghai Henlius Biotech Inc., a leading biopharmaceutical company based in China and listed on the...
Allgens Medical Technology’s BonGold Receives Marketing Approval from Malaysia’s MDA
Allgens Medical Technology Co., Ltd, a Beijing-based innovator in regenerative medicine materials and implantable devices...
Regeneron’s Linvoseltamab Faces FDA Complete Response Letter, Awaiting Reinspection of Manufacturer
Regeneron Pharmaceuticals Inc., a leading biopharmaceutical company based in the US and listed on the...
Innovent Biologics’ Fulzerasib Receives NMPA Approval for Advanced NSCLC Treatment in China
Innovent Biologics Inc., a biopharmaceutical company based in China and listed on the Hong Kong...
Qilu Pharmaceutical’s Biosimilar Ranibizumab Receives NMPA Approval, Marking a First in China
Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its biosimilar version of Novartis’s blockbuster...
J&J’s Rybrevant-Lazclude Combo Approved by FDA, Challenging AstraZeneca’s Tagrisso in NSCLC Treatment
Johnson & Johnson (J&J; NYSE: JNJ) has secured a new market approval in the United...
Johnson & Johnson’s Rybrevant-Lazclude Combo Approved by FDA for First-Line NSCLC Treatment
NEW YORK—Healthcare conglomerate Johnson & Johnson (J&J; NYSE: JNJ) has secured a significant regulatory milestone...
MicroPort MedTech’s ReeAmber Catheter Wins NMPA Nod for Peripheral Artery Treatments
SHANGHAI—Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a leading player in the medical device...
Astellas Pharma’s Padcev Receives NMPA Approval for Urothelial Cancer Treatment
TOKYO—Astellas Pharma Inc. (TYO: 4503) has announced that its anti-HER3 antibody-drug conjugate (ADC), Padcev (enfortumab...
China’s NMPA Grants Medical Device License to DaAn Gene’s Monkeypox Detection Kit
GUANGZHOU—DaAn Gene Co., Ltd, a subsidiary of Sun Yat-sen University based in China (SHE: 002030),...
Changchun High & New Technology Secures NMPA Approval for Turner Syndrome Treatment
CHANGCHUN—Changchun High & New Technology Industries (Group) Inc., (SHE: 000661), a leading biopharmaceutical company in...
AstraZeneca’s Fasenra Secures NMPA Approval for Severe Eosinophilic Asthma Maintenance Therapy
BEIJING—The National Medical Products Administration (NMPA) of China has granted market approval for AstraZeneca (NASDAQ:...
Genmab’s Tepkinly/Epkinly Receives EC Nod for Relapsed Lymphoma Treatments
COPENHAGEN—Genmab A/S (NASDAQ: GMAB), a leading biotech company, has announced that the European Commission (EC)...
Lepu Medical Secures Approval for RECATCHOR Catheter, Enhancing Cardiovascular Procedures
Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading provider of cardiovascular disease solutions...
Robotrak Secures NMPA License for China’s First Smart Ophthalmic Navigation Laser
Robotrak, a Nanjing-based ophthalmic innovation platform, has secured a Category III medical device license from...
Lepu Scientech Secures NMPA Approval for MemoSORB Biodegradable Atrial Septal Defect Occluder
Lepu Scientech Medical Technology (Shanghai) Co., Ltd. (HKG: 2291) has announced that it has received...
Sino Medical Secures Moroccan Approvals for NC Rockstar Catheter and HT Supreme Stent System
Sino Medical Sciences Technology Inc. (SHA: 688108), a prominent player in China’s medical device sector,...