Novo Nordisk’s Semaglutide 7.2 mg sNDA Submitted for Weight Management
Novo Nordisk A/S (NYSE: NVO) announced the submission of a supplemental New Drug Application (sNDA)...
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)...
Bio-heart’s IberiRDN Wins New Zealand Nod as Only Dual-Approach Renal Denervation System
Shanghai Bio-heart Biological Technology Co., Ltd. (HKG: 2185) announced that its Iberis Multi-Electrode Renal Denervation...
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...
Novartis’ Remibrutinib Wins NMPA Approval for Chronic Spontaneous Urticaria
Novartis AG (NYSE: NVS) announced that remibrutinib tablets received National Medical Products Administration (NMPA) approval...
CMS IRA Drug-Pricing Round 2 Delivers 62% Average Cut, Ozempic Falls 71%
The U.S. Centers for Medicare & Medicaid Services (CMS) announced results of the second round...
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...
Kelonia JNJ Partnership Targets In Vivo CAR-T for Multiple Myeloma
Kelonia Therapeutics announced a strategic collaboration with Johnson & Johnson (J&J, NYSE: JNJ) to develop...
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...
Wuzhong Pharma Faces Mandatory Delisting After CSRC Violations
Jiangsu Wuzhong Pharmaceutical Group Corp. (SHA: 600200) received an Administrative Penalty Decision ( No. 145) from...
Novartis’s Itvisma Wins FDA Approval as First Gene Therapy for SMA
Novartis AG (NYSE: NVS) announced that Itvisma (onasemnogene abeparvovec‑brve) received U.S. FDA approval for children...