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...
Product approvals
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,...
Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy
Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has secured market approval in the...
Biogen and Eisai Secure UAE Approval for Alzheimer’s Therapy Leqembi
Biogen Inc. (NASDAQ: BIIB), based in the U.S., and Japan’s Eisai Co., Ltd. have announced...
China’s Sansure Biotech Launches Approved Kit for Alzheimer’s and Cardiovascular Risk Assessment
Sansure Biotech Inc. (SHA: 688289), a China-based leader in molecular diagnostics, has secured marketing approval...
Qilu Pharmaceutical Gains Approval for Generic Dasatinib, Expanding CML Treatment Options in China
Qilu Pharmaceutical, based in China, has received marketing approval for its generic version of Bristol-Myers...