Johnson & Johnson Wins U.S. 510(k) Clearance for MONARCH QUEST 3 Software Update – Advancing Robotic Bronchoscopy Navigation and Targeting
Johnson & Johnson (J&J, NYSE: JNJ) announced U.S. 510(k) regulatory clearance for MONARCH QUEST 3,...
Trump Picks White House Policy Advisor Heidi Overton to Lead FDA – Replacing Acting Commissioner Kyle Diamantas After Makary’s Resignation
U.S. President Donald Trump has chosen White House policy advisor Heidi Overton to lead the...
Shanghai Yizhong Pharmaceutical’s YXC‑002 Wins IND Approval – Fourth‑Generation Brain‑Penetrant EGFR‑TKI for Non‑Small Cell Lung Cancer Overcomes C797S Resistance
Shanghai Yizhong Pharmaceutical Co., Ltd (SHA: 688091) announced that the Investigational New Drug (IND) application...
Genrix Bio’s GR2302 Bispecific Antibody Receives NMPA IND Approval for Chronic Hepatitis B – TCR‑Mimic T‑Cell Engager Targets HBV‑Infected Hepatocytes
Chongqing Genrix Bio Pharmaceutical Co., Ltd. (SHA: 688443) announced that its investigational product GR2302 (subcutaneous...
Novo Nordisk China Launches Organizational Restructuring – Merges Diabetes and Insulin Divisions into Hospital Business Division, Creates New Emerging Channels Division
Novo Nordisk A/S China (NYSE: NVO) announced the initiation of an organizational restructuring of its...
Nhwa Pharmaceutical Wins NMPA IND Approval for Two Category 1 Chemical Drugs – NH130 for Schizophrenia & Alzheimer’s Psychosis, NH302 for Acute Pain
Nhwa Pharmaceutical Co., Ltd. (SHE: 002262) announced that its two Category 1 chemical drugs, NH130...
CSPC Pharmaceutical’s Anbenitamab (KN026) Plus HB1801 NDA Accepted by NMPA for First‑Line Advanced Breast Cancer – HER2 Bispecific Combo Advances in China
CSPC Pharmaceutical Group Limited (HKG: 1093) announced that the New Drug Application (NDA) for its...
Bio-Thera Solutions Expands Partnership with Avalon Pharma: Exclusive MENA Licensing Deal for Dupixent Biosimilar BAT2406 – Second Collaboration After BAT3306
Bio-Thera Solutions, Ltd. (SHA: 688177) and Saudi Arabia‑headquartered Avalon Pharma announced the expansion of their...
Betta Pharmaceuticals Partner EyePoint Reports EYP‑1901 Misses Primary Endpoint in First Pivotal Phase III LUGANO Trial for Wet AMD – DURAVYU Fails Non‑Inferiority vs. Aflibercept
Betta Pharmaceuticals Co., Ltd. (SHE: 300558) announced that its partner EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT)...
OmniAb Signs Global Collaboration and License Agreement with Eli Lilly for Ion Channel Program – Up to $370 Million in Milestones Plus Royalties
OmniAb, Inc. (NASDAQ: OABI) announced a global collaboration and license agreement with Eli Lilly (NYSE:...
European Commission Revokes EU Marketing Authorisation for CSL and VFMCRP’s TAVNEOS – Avacopan Withdrawn Across EU and EEA Markets
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and CSL announced that the European Commission (EC)...
Navi Therapeutics Completes Angel and Series A Rounds Totaling Several Hundred Million RMB – Legend Capital Co‑Leads Backing for Next‑Generation ADC Platform
Navi Therapeutics (Shanghai) Co., Ltd. announced the successful completion of two financing rounds — Angel...
Shanghai Yizhong’s First‑in‑Class Tri‑Specific Biologic YXC‑001 Wins NMPA Clinical Trial Approval for Advanced Solid Tumors
Shanghai Yizhong Pharmaceutical Co., Ltd (SHA: 688091) announced that its Category 1 therapeutic biologic YXC‑001,...
CANbridge Pharmaceuticals’ Livmarli Granted NHIA Reimbursement Approval in Taiwan – IBAT Inhibitor Coverage for ALGS and PFIC Takes Effect September 1
CANbridge Pharmaceuticals Inc. (HKG: 1228) announced that its rare disease drug Livmarli (Maralixibat Chloride Oral...
Ledeinno Medical Valley Closes Over 200 Million RMB in Series B+ and B++ Rounds – Shining Capital Leads Backing for Wireless SCS Neuromodulation Platform
Ledeinno Medical Valley announced the completion of its Series B+ and Series B++ funding rounds...
Enginprime Medical Closes Nearly 100 Million RMB Series A Round with Qiming Venture Partners as Sole Investor – Capital Earmarked for OpusOne pVAD Clinical Trials
Enginprime Medical announced the completion of its Series A funding round of nearly 100 million...
AstraZeneca Launches Tezspire in China, Bringing First‑In‑Class TSLP Inhibitor Tezepelumab to Severe Asthma and CRSwNP Patients
AstraZeneca plc (NYSE: AZN) announced the official market launch in China of Tezspire (generic name:...
Guangdong Regulator Issues Recall, Traceability and Emergency Response Rules for Imported Hong Kong–Macao Pharmaceuticals and Medical Devices in GBA
The Guangdong Medical Products Administration issued three landmark policy documents governing imported Hong Kong and...
Fosun Pharma Launches Phase 2 Trial of FXS7553 DPP‑1 Inhibitor for COPD in China
Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced that FXS7553 has initiated a...
Asieris Pharmaceuticals Wins FDA Clearance for APL‑2501, an Anti‑CLDN6/9 ADC in Advanced Solid Tumors
Jiangsu Asieris Pharmaceuticals Co., Ltd. (SHA: 688176) announced that its independently developed APL‑2501 has received...