Henlius Biotech’s HLX04-O Shows Positive Results in wAMD Phase III Trial
China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced positive results from the Phase III...
Drug
Mabwell Bioscience’s 7MW3711 ADC Receives Clinical Trial Approval in China
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that it has received clinical trial...
Novartis’ Vanrafia Gets FDA Accelerated Approval for IgAN
Switzerland-based Novartis (NYSE: NVS) announced that it has received accelerated approval from the US Food...
Shionogi Partners with Link Medical for Cefiderocol Development in Australia and New Zealand
Japan-based Shionogi Co., Ltd. has entered into an exclusive licensing agreement with Link Medical Products...
Guojian Qingke Biomedical Gains NMPA Approval for 3D MSCs in Stroke Trials
China-based Guojian Qingke Biomedical Technology (Beijing) Co., Ltd. announced that it has received tacit clinical...
Gan & Lee Pharmaceuticals Secures Pakistan Approval for Insulin Glargine Cartridge
Gan & Lee Pharmaceuticals (SHA: 603087) has announced the receipt of marketing approval for its...
Biogen’s BIIB080 Receives FDA Fast Track Designation for Alzheimer’s
US-based Biogen Inc. (NASDAQ: BIIB) announced that it has received Fast Track designation (FTD) from...
Novartis’ Fabhalta Approved in China for C3 Glomerulopathy
Novartis’ (NYSE: NVS) Fabhalta (iptacopan) has received approval from China’s National Medical Products Administration (NMPA)...
Shionogi Submits Rolling NDA for Ensitrelvir in US for COVID-19 Prophylaxis
Shionogi announced on April 1, 2025, the initiation of a rolling New Drug Application (NDA)...
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...
AccurEdit’s ARTbase-A1 Base Editor Authorized by USPTO
On April 2, 2025, China-based AccurEdit Therapeutics (Suzhou) Co., Ltd., a specialist in gene editing...
Zhifei Bio’s Trivalent Influenza Vaccine Approved for Clinical Trials in China
Zhifei Biological (SHE: 300122) announced on April 1, 2025, that its subsidiary Zhifei Longcom has...
Henlius and Organon’s HLX11 Biosimilar Clears EMA Validation Hurdle
Shanghai Henlius Biotech, Inc. (HKG: 2696) and Organon (NYSE: OGN) announced that the European Medicines...
Huadong Medicine’s Semaglutide Injection Accepted for Review by China’s NMPA
China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that the National Medical Products Administration (NMPA)...
Hengrui Pharmaceuticals Secures Clinical Trial Approval for HRS-9813 in IPF
Hengrui Pharmaceuticals (SHA: 600276) announced on April 1, 2025, that its HRS-9813 capsule has received...
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...
BeiGene’s Tevimbra Recommended for EU Approval in Small Cell Lung Cancer
BeiGene, Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), the China-based oncology specialist proposing to rename...
Otsuka Files FDA Application for Sibeprenlimab in IgAN Treatment
Japan-based Otsuka Pharmaceutical Co., Ltd. announced the filing of a Biologics License Application (BLA) with...
UCB’s Rystiggo Approved in China for Generalized Myasthenia Gravis
Belgium-based biopharma UCB (EBR: UCB) announced that it has received marketing approval from China‘’s National...
AstraZeneca and Daiichi Sankyo Initiate DESTINY-Gastric05 Study for Enhertu in Metastatic Gastric Cancer
Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced the first patient dosing in...