Amgen’s Uplizna Approved by FDA for IgG4-Related Disease
US biotech giant Amgen (NASDAQ: AMGN) announced that it has received marketing approval from the...
Product approvals
J&J’s Rybrevant SC Formulation Approved by EC for NSCLC Treatment
The European Commission (EC) has approved the subcutaneous (SC) formulation of Johnson & Johnson’s (J&J,...
J&J’s Darzalex SC Formulation Approved for Newly Diagnosed Multiple Myeloma
Johnson & Johnson (J&J, NYSE: JNJ) announced that it has received clearance from the European...
Luye Pharma’s Toludesvenlafaxine Approved for Marketing in Macau
China-based Luye Pharma Group (HKG: 2186) announced that its extended-release depression treatment, toludesvenlafaxine (LY03005), has...
Nanjing King-Friend Bio’s Biosimilar Victoza Approved by FDA
China-based Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd (SHA: 603707) announced that its Abbreviated New Drug...
Santen’s Tapcom Approved by China’s NMPA for Glaucoma Treatment
Japan-based Santen Pharmaceutical Co., Ltd. announced that it has received marketing approval from China’s National...
Enhertu Approved by EC for Earlier-Line Treatment of HR+/HER2-low Breast Cancer
Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced that they have received approval...
MicroPort Endovascular’s Talos Stent Approved in Brazil for Aortic Dissection
Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016) announced that it has received marketing approval...
Fujian Kerui’s Generic Sirolimus Gel Approved by China’s NMPA
China-based Fujian Kerui Pharmaceutical Co., Ltd. announced that its generic version of Pfizer’s (NYSE: PFE)...
Novartis’ Vanrafia Gets FDA Accelerated Approval for IgAN
Switzerland-based Novartis (NYSE: NVS) announced that it has received accelerated approval from the US Food...
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...