Hengrui’s Recaticimab Approved for Hypercholesterolemia Treatment
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that its Category 1 biologic...
Product approvals
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...
Amgen’s Imdylltra Gains Conditional Approval in UK for Extensive-Stage Small Cell Lung Cancer
US biotech company Amgen (NASDAQ: AMGN) has received conditional approval from the UK’s Medicines and...
Junshi Biosciences’ Loqtorzi Gains Regular Approval for Melanoma Treatment in China
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that its PD-1 inhibitor,...
GSK’s Nucala Receives New Indication Approval in China for CRSwNP
UK-based pharmaceutical company GlaxoSmithKline’s (GSK; NYSE: GSK) has announced that it has received another indication...
AstraZeneca’s Tagrisso Receives NMPA Approval for EGFR-Mutated NSCLC Treatment
UK-based AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received a new indication approval...
NMPA Approves Lynparza as Adjuvant Treatment for High-Risk Breast Cancer Patients
The National Medical Products Administration (NMPA) in China has granted AstraZeneca (AZ, NASDAQ: AZN) and...
Gilead Sciences’ Sunlenca Receives NMPA Approval for Multidrug-Resistant HIV-1 Infection
US-based pharmaceutical company Gilead Sciences Inc., (NASDAQ: GILD), has announced that it has received marketing...
Innovent Biologics’ Taletrectinib Gains NMPA Approval for ROS1 Positive NSCLC
China-based Innovent Biologics, Inc. (HKG: 1801) has announced receiving an additional marketing approval from the...
MabPharm’s CMAB807 Biosimilar Infliximab Approved in Pakistan
Taizhou-based monoclonal antibody (mAb) biosimilar specialist MabPharm Ltd (HKG: 2181) has announced the receipt of...
NMPA Grants Conditional Approval for China’s First MSCs Therapy for aGVHD
The National Medical Products Administration (NMPA) in China has conditionally approved amimestrocel from Beijing-based Platinum...
Genesis MedTech’s iReach Omnia Receives NMPA Approval for Rectal Cancer Surgery
Singapore-based medical device company Genesis MedTech has announced that it has received marketing approval from...