Novartis’ Vanrafia Gets FDA Accelerated Approval for IgAN
Switzerland-based Novartis (NYSE: NVS) announced that it has received accelerated approval from the US Food...
Product approvals
Sihuan Pharma’s Polycaprolactone Microsphere Filler Gains NMPA Approval
China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) announced that it has received Category III...
Gan & Lee Pharmaceuticals Secures Pakistan Approval for Insulin Glargine Cartridge
Gan & Lee Pharmaceuticals (SHA: 603087) has announced the receipt of marketing approval for its...
Novartis’ Fabhalta Approved in China for C3 Glomerulopathy
Novartis’ (NYSE: NVS) Fabhalta (iptacopan) has received approval from China’s National Medical Products Administration (NMPA)...
Pfizer Expands Abrysvo RSV Vaccine Indication to Include Ages 18-59 in EU
Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has amended the marketing...
Sino Medical Sciences Secures Malaysian Approval for Coronary Balloon Catheter
China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced receiving marketing approval in Malaysia...
Luye Pharma’s Weekly Rivastigmine Patch Approved in Japan for Alzheimer’s
China-based Luye Pharma Group (HKG: 2186) announced that it has received marketing approval from Japan’s...
Hengrui Pharmaceuticals’ Ivarmacitinib Approved for Rheumatoid Arthritis in China
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received additional indication approval...
Huapont Life Sciences Gains NMPA Approval for Generic Daivobet
China-based Huapont Life Sciences Co., Ltd (SHE: 002004) announced that it has received marketing approval...
Sanofi’s Dupixent Approved in Japan for Chronic Obstructive Pulmonary Disease
Sanofi (EPA: SAN, NASDAQ: SNY) announced that it has received approval from Japan’s Ministry of...
Novartis’ Pluvicto Gains Expanded FDA Approval for Prostate Cancer Treatment
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that it has received expanded indication approval from...
BMS’s Opdivo/Yervoy Combo Approved by NMPA for First-Line HCC Treatment
Bristol-Myers Squibb (BMS, NYSE: BMY) announced that it has received approval from China’s National Medical...
Roche’s Ocrevus Approved by China’s NMPA for Multiple Sclerosis Treatment
Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) announced that it has received marketing approval...
AstraZeneca’s Imfinzi Approved by FDA for Bladder Cancer Treatment
The US Food and Drug Administration (FDA) has approved AstraZeneca’s (NASDAQ: AZN) PD-L1 inhibitor Imfinzi...
Sanofi’s Qfitlia Approved by FDA for Hemophilia A and B Prophylaxis
France-based Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving marketing approval from the US Food...
IASO Biotherapeutics’ Fucaso Approved in Macao for Relapsed Multiple Myeloma
China-based IASO Biotherapeutics announced that the New Drug Application (NDA) for its BCMA-targeted chimeric antigen...
Abbott Laboratories’ Volt PFA System Receives EU CE Mark for Atrial Fibrillation Treatment
US-based Abbott Laboratories (NYSE: ABT) has announced the receipt of the CE mark in the...
Genmab’s Tivdak Approved in Japan for Advanced Cervical Cancer Treatment
Denmark-based Genmab A/S (NASDAQ: GMAB) has secured approval from the Japan Ministry of Health, Labour...
NMPA Approves Qingfeng’s Suraxavir Marboxil for Influenza A and B Treatment
China’s National Medical Products Administration (NMPA) has approved suraxavir marboxil, a Category 1 drug developed...
YiChang HEC’s Yiqibuvir Approved by NMPA for Chronic HCV Infection
China-based YiChang HEC ChangJiang Pharmaceutical Co., Ltd. (HKG: 1558) announced receiving marketing approval from the...