J&J Darzalex Faspro Gets FDA Nod for NDMM D-VRd Regimen
Johnson & Johnson (J&J, NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) approved...
Roche CT-388 Obesity Drug Shows 22.5% Weight Loss in Phase II Trial
Roche (SWX: ROG, OTCMKTS: RHHBY) announced positive topline results from its Phase II clinical trial (CT388‑103)...
FDA Removes Suicide Warnings from GLP‑1 Drugs After Investigation Finds No Causal Link
The U.S. Food and Drug Administration this month requested that Novo Nordisk and Eli Lilly...
Leqvio Gets NMPA Nod for Monotherapy in China Hypercholesterolemia
Novartis (NYSE: NVS) announced that Leqvio (inclisiran) has received an additional indication approval from the National...
Apeloa Partners with MindRank on AI Drug Development Platform
Apeloa Pharmaceutical Co., Ltd. (SHE: 000739), a China‑based contract development and manufacturing organization (CDMO), announced...
China Drug Administration Implementation Regulations Set for May 2026 Launch
China’s State Council this week issued the Implementation Regulations of the Drug Administration Law, a...
Henlius Triple Combo Gets NMPA Nod for Advanced Solid Tumor Trials
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced it has received National Medical Products Administration (NMPA)...
Hengrui’s HRS-5346 Lp(a) Inhibitor Gets China Breakthrough Therapy Designation in $1.97B Merck Deal
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that HRS-5346, the centerpiece of a USD 1.97 billion...
IVD Medical Launches Nipah Virus Detection Kit with AI Early Warning Platform
IVD Medical Holding Ltd (HKG: 1931), a China‑based in vitro diagnostic specialist, announced the launch...
Betta Pharmaceuticals’ BPI-572270 RAS Inhibitor Gets NMPA Nod for Solid Tumor Trials
Betta Pharmaceuticals (SHE: 300558) announced that the National Medical Products Administration (NMPA) has approved the...
Nanjing Leads Biolabs Secures FDA Fast Track for LBL-034 in Multiple Myeloma
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced that LBL-034, a GPRC5D/CD3 bispecific antibody (BsAb) T‑cell...
NMPA Suspends Two Indian Pharma APIs Over GMP Violations
China’s National Medical Products Administration (NMPA) announced enforcement actions against two India‑based active pharmaceutical ingredient...
Zhaoke Ophthalmology Expands BRIMOCHOL PF Presbyopia Distribution to Singapore and Vietnam
Zhaoke Ophthalmology (HKG: 6622) announced expanded distribution agreements for BRIMOCHOL PF to include Singapore and...
Innovent Biologics Secures FDA Fast Track for IBI3003 Trispecific Antibody in Multiple Myeloma
Innovent Biologics, Inc. (HKG: 1801) announced that the U.S. Food and Drug Administration (FDA) has...
Acrobiosystems Files for Hong Kong IPO as Life Science Tools Leader
Acrobiosystems Co., Ltd. made its initial public offering filing to the Hong Kong Stock Exchange,...
Aucta Pharma Files for Hong Kong IPO with CNS and Rare Disease Pipeline
Shanghai Aucta Pharmaceuticals Co., Ltd. made its initial public offering (IPO) filing to the Hong...
Bio-heart Secures Indonesia Approval for Iberis RDN System
Shanghai Bio-heart Biological Technology Co., Ltd. (HKG: 2185) announced market approval in Indonesia for its...
BioArctic Partner Eisai Submits EMA Application for Four-Week Lecanemab Dosing in Alzheimer’s
BioArctic AB (OTCMKTS: BRCTF) partner Eisai (TYO: 4523) announced submission of a proposed Marketing Authorisation Variation...
Nuance Pharma Secures NMPA Review for Ensifentrine COPD Maintenance Therapy
Nuance Pharma announced that its market filing for Ohtuvayre (ensifentrine) as maintenance treatment for patients...