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...
Drug
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...
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)...
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...
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...
Novartis’ Remibrutinib Wins NMPA Approval for Chronic Spontaneous Urticaria
Novartis AG (NYSE: NVS) announced that remibrutinib tablets received National Medical Products Administration (NMPA) approval...
Hengrui’s Three Oncology Assets Win NMPA Clinical Trial Approval
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that three of its investigational...
Humanwell’s Lisdexamfetamine NDA Accepted by NMPA for ADHD, First Generic Potential
Humanwell Healthcare (Group) Co., Ltd. (SHA: 600079) announced that the National Medical Products Administration (NMPA)...
Innovent’s mazdutide 9mg Obesity Application Accepted by NMPA
Innovent Biologics, Inc. (HKG: 1801) announced that China’s National Medical Products Administration (NMPA) has accepted...
Fosun’s Luvometinib Gets NMPA Priority Review for Pediatric LCH
Fosun Pharma (SHA: 600196, HKG: 2196) announced that the National Medical Products Administration (NMPA) has...
Otsuka’s VOYXACT Wins FDA Accelerated Approval for IgAN, First APRIL Blocker
Otsuka Pharmaceutical (OTCMKTS: OTSKY) announced that VOYXACT (sibeprenlimab‑szsi) received U.S. FDA Accelerated Approval for reducing...