iRegene’s NouvNeu004 Wins FDA Special Exemption for MSA Cell Therapy
iRegene Therapeutics announced that the U.S. FDA granted Special Exemption status to NouvNeu004 injection, approving...
Company
Proviva’s PTX-912 PD-1 IL-2 Fusion Gets USD 30M Series A+ Boost
Proviva Therapeutics announced the completion of a Series A+ financing round, raising over USD 30 million led...
Pfizer-Astellas’ PADCEV Wins FDA Approval for Perioperative Bladder Cancer
Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TYO: 4503) announced that the U.S. Food...
GenSci’s GenSci142 Wins NMPA Nod for Bacterial Vaginosis Clinical Trials
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) announced that its subsidiary GenSci...
Jiuzhou Pharmaceutical Wins Tentative FDA Approval for Generic Janumet XR
Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (SHA: 603456) announced that its Abbreviated New Drug Application (ANDA)...
Hengrui’s Ivarmacitinib Wins NMPA Nod for Vitiligo Clinical Trials
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that Ivarmacitinib Tablets and SHR0302...
Juventas CAR-T Wins Second China Approval for Lymphoma, Expands Hematology Franchise
Juventas Cell Therapy Ltd. announced that inaticabtagene autoleucel (CNCT 19), China’s first self‑developed CD19‑targeting CAR‑T...
Innovent’s Picankibart Wins NMPA Approval for Psoriasis as IL-23p19 Inhibitor
Innovent Biologics, Inc. (HKG: 1801) announced that Picankibart Monoclonal Antibody Injection (IBI112), branded XINMEIYUE, received...
Trulive Medical Closes Series C, Raising Over RMB 100M for Cardiovascular Innovation
Jiangsu Trulive Medical announced the completion of a Series C financing round raising over RMB...
Boan Biotech’s Boyoujing Aflibercept Wins NMPA Approval for Retinal Diseases
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that its self‑developed Aflibercept Intravitreal Injection (Boyoujing)...
Sprint-Bioscience Sells TREX1 Program to Gilead for $14M Upfront
Sprint Bioscience AB announced the sale of its TREX1 cancer program to Gilead Sciences, Inc....
MicroTech’s LinX CGM Wins India Approval, Expanding Asia Diabetes Monitoring
MicroTech Medical (Hangzhou) Co., Ltd. (HKG: 2235) announced that its LinX Continuous Glucose Monitoring (CGM)...
IASO-Bio’s Fucaso Wins Hong-Kong Approval as First China CAR-T
IASO Biotherapeutics announced that Fucaso (equecabtagene autoleucel injection), its proprietary fully human BCMA‑targeted CAR‑T cell...
BeOne’s Sotoclax Wins FDA Priority Review for Mantle Cell Lymphoma
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that the U.S. FDA has accepted its...
Patronus Biotech Gates Foundation Grant Accelerates Malaria Vaccine Development
Patronus Biotech Pte. Ltd. announced it has received a grant from the Gates Foundation to...
Innova Therapeutics Acquires Enci Therapeutics’ IVT-8086 Cancer Program
Innova Therapeutics announced the acquisition of Enci Therapeutics, gaining its primary cancer therapeutic program IVT‑8086,...
Gene Key’s iNKT Cell Therapy Wins NMPA Nod for ARDS, First Allogeneic Ready-to-Use
Beijing Gene Key Life Technology Co., Ltd. announced that its GKL‑006RTU Injection, China’s first novel...
SciClone’s Meropenem-Vaborbactam Wins GBA Approval as First Antibiotic Under Medical Connect
SciClone Pharmaceuticals Inc. announced that Meropenem/Vaborbactam for Injection has been approved under the “Hong Kong-Macau...