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)...
Drug
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...
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...
Ascletis Pharma’s ASC30 Shows Positive Results in US Phase Ib Obesity Study
China-based Ascletis Pharma Inc. (HKG: 1672) announced positive interim results from a Phase Ib study...
Innovent Biologics’ IBI363 Granted Breakthrough Therapy Designation for Melanoma
China-based Innovent Biologics, Inc. (HKG: 1801) announced that it has received breakthrough therapy designation (BTD)...
Hengrui’s HRS-5965 Granted Breakthrough Therapy Designation for IgA Nephropathy
China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced that it has received breakthrough therapy...
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...
EMA’s CHMP Issues Negative Opinion on Lilly’s Kisunla for Alzheimer’s
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...