Telix Pharmaceuticals’ TLX591-CDx Approved in Europe via Decentralized Procedure
Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) has announced that the marketing filing in Europe via...
Product approvals
Impact Therapeutics’ Senaparib Cleared by NMPA for Ovarian Cancer Therapy
China-based Impact Therapeutics has announced receiving marketing clearance from the National Medical Products Administration (NMPA)...
Innovent’s Limertinib Wins NMPA Approval for NSCLC Treatment
China-based Innovent Biologics, Inc. (HKG: 1801) has announced that it has received New Drug Application...
HutchMed’s Orpathys Approved for Expanded NSCLC Indication in China
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that the National Medical Products Administration...
Roche’s VENTANA Kappa and Lambda Dual ISH Test Gains FDA Clearance
Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced that it has received marketing...
MGI Tech’s DNBSEQ-E25 Receives NMPA License as World’s First Self-Luminescent Sequencer
China-based gene sequencing specialist MGI Tech Co., Ltd has announced that it has received a...
Medtronic’s BrainSense Technologies Win EU, UK CE Mark for Parkinson’s Treatment
US-Irish firm Medtronic (NYSE: MDT) has announced that it has received CE (Conformité Européenne) Mark...
CSPC’s Prusogliptin Approved in China for Type 2 Diabetes Treatment
China’s National Medical Products Administration (NMPA) has granted marketing approval to CSPC Pharmaceutical Group Co.,...
Johnson & Johnson MedTech’s Dual Energy Catheter Gains CE Mark
US major Johnson & Johnson MedTech has announced that its Dual Energy THERMOCOOL SMARTTOUCH SF...
Junshi Biosciences’ Mindewei Receives Full Approval in China
China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that the conditional...
Hengrui’s Recaticimab Approved for Hypercholesterolemia Treatment
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that its Category 1 biologic...
NMPA Approves J&J’s FGFR Kinase Inhibitor Balversa for Urothelial Carcinoma
China’s National Medical Products Administration (NMPA) has approved Johnson & Johnson’s (J&J; NYSE: JNJ) FGFR...
Roche Gains FDA 510(k) Clearance for Roche Digital Pathology Dx with VENTANA DP 600
Swiss giant Roche (SWX: ROG, OTCMKTS: RHHBY) has announced an additional 510(k) clearance from the...
Astellas’ Padcev and Keytruda Combo Cleared by NMPA for Urothelial Cancer
Japan-based Astellas Pharma Inc. (TYO: 4503) has announced marketing clearance by China’s National Medical Products...
Kelun Pharmaceutical’s Generic Mulpleta Gains NMPA Approval in China
China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that it has received marketing...
Medtronic’s Harmony TPV System Gains CE Mark for Minimally Invasive Heart Valve Treatment
US-Irish firm Medtronic (NYSE: MDT) has announced that its Harmony Transcatheter Pulmonary Valve (TPV) System...
Sanofi’s Sarclisa Gains NMPA Approval for Multiple Myeloma Treatment in China
French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from...
MSD’s Gardasil Vaccine Gains NMPA Approval for Use in Males Aged 9 to 26
US major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that it has received...
GE Healthcare’s Allia IGS Pulse Receives NMPA Clearance for Launch in China
US medical device and life sciences giant GE Healthcare Technologies Inc. (NASDAQ: GEHC) has announced...
Eyebright Medical’s Loong Crystal PR Receives NMPA Class III Medical Device Approval
China-based Eyebright Medical Technology (Beijing) Co., Ltd. (SHA: 688050) has announced that it has received...