Gaush Meditech’s Corneal Confocal Microscope Approved in Jiangsu
Suzhou-based Gaush Meditech Ltd (HKG: 2407) announced that it has received market approval from the...
Product approvals
AbbVie’s Rinvoq Approved in EU for Giant Cell Arteritis
US-based pharmaceutical giant AbbVie (NYSE: ABBV) announced that it has received marketing approval in the...
Bristol-Myers Squibb’s Opdivo/Yervoy Combo Approved for MSI-H Colorectal Cancer
Bristol-Myers Squibb (BMS, NYSE: BMY) announced this week that the US Food and Drug Administration...
Yifan Pharma Secures NMPA Approval for Generic Sedapain
China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced that it has received marketing approval...
Daiichi Sankyo and AstraZeneca’s Datroway Approved in EU for Breast Cancer
Japan-based Daiichi Sankyo (TYO: 4568) and UK major AstraZeneca (NASDAQ: AZN) announced that their co-developed...
Hengrui Pharmaceuticals’ Vunakizumab Approved for Ankylosing Spondylitis
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received additional indication approval...
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...
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...