FDA Approves Boehringer’s Zongertinib in Record 44 Days – First Oral HER2 TKI Wins CNPV Fast‑Track
The U.S. Food and Drug Administration (FDA) approved zongertinib (Hernexeos), developed by Boehringer Ingelheim, in...
WuXi XDC Licenses WuXiTecan-2 Technology to Earendil Labs – $885M Deal Powers AI‑Driven ADC Development
WuXi XDC (HKG: 2268), a leading global end‑to‑end CRDMO, announced a strategic collaboration with Earendil Labs,...
MSD’s Prevymis Wins NMPA Approval for 200‑Day Pediatric CMV Prophylaxis – Extended Post‑Transplant Protection
Merck & Co. (MSD, NYSE: MRK) announced that Prevymis (letermovir), its novel non‑nucleoside cytomegalovirus (CMV) inhibitor,...
SteinCares Partners with Shilpa Biologicals on Latin America Biosimilar Deal – Regional Commercialization Agreement
SteinCares, a leading specialty healthcare company in Latin America, and Shilpa Biologicals Pvt. Ltd. (SBPL),...
NMPA Approves 76 Innovative Medical Devices in 2025 – 17% YoY Growth Driven by AI and Priority Review Surge
The National Medical Products Administration (NMPA) released its 2025 Annual Medical Device Registration Report, highlighting...
Fosun Pharma’s Luvometinib Cleared for Phase II NSCLC Combination Trial – MEK Inhibitor Plus Anlotinib Targets KRAS Mutations
Shanghai Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196, SHA: 600196) announced NMPA approval to initiate a Phase...
NMPA CDE Opens Public Consultation for 104th Reference Listed Drugs Catalog – 63 Specifications Under Review
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) officially opened...
Danaher to Acquire Masimo for $9.9B – Expands Diagnostics Platform with Pulse Oximetry Leader
Danaher Corporation announced a definitive agreement to acquire Masimo Corporation (NASDAQ: MASI), a leading professional diagnostics...
Novartis to Build $23B RLT Manufacturing Site in Texas – Expands Radioligand Therapy Production Capacity
Novartis (NYSE: NVS) announced plans to establish a new 46,000‑square‑foot radioligand therapy (RLT) manufacturing site in...
Novo Nordisk Partners with Vivtex on $2.1B Oral Biologics Deal – Targets Obesity and Diabetes Delivery Innovation
Novo Nordisk (NYSE: NVO) announced a strategic partnership with Vivtex Corporation to co-develop next‑generation oral biologic...
3SBio’s SSGJ-611 NDA Accepted by NMPA – Anti-IL-4Rα mAb Targets Moderate-to-Severe Atopic Dermatitis
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd (SHA: 688336), a subsidiary of 3SBio Inc. (HKG: 1530), announced that...
Kexing Biopharma’s GB19 Wins NMPA IND Approval – Novel BDCA2 Targeted Therapy for Lupus Enters Clinic
Kexing Biopharma (SHA: 688136) announced that China’s National Medical Products Administration (NMPA) has cleared GB19 Injection...
Lepu Biopharma’s GPC3 ADC MRG006A Wins NMPA Approval for HCC Combination Trials – First‑in‑Class Asset Advances
Lepu Biopharma Co., Ltd (HKG: 2157) announced that China’s National Medical Products Administration (NMPA) has approved...
GSK to Acquire 35Pharma for $950M – Adds Potential Best‑in‑Class PAH Asset HS235
GlaxoSmithKline (GSK, NYSE: GSK) announced a definitive agreement to acquire 35Pharma Inc., a Canada‑based clinical‑stage biopharmaceutical...
FDA Approves AstraZeneca’s Calquence Plus Venetoclax for CLL/SLL – First All‑Oral Fixed‑Duration Regimen
AstraZeneca (AZ, NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) has approved the...
Dupixent Wins FDA Approval for Allergic Fungal Rhinosinusitis – First Targeted Therapy for AFRS Expands Dupilumab Label
Sanofi (NASDAQ: SNY) and Regeneron (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has...
Astellas and Vir Biotechnology Partner on $1.7B+ PRO-XTEN TCE Deal – VIR-5500 Targets PSMA in Prostate Cancer
Astellas Pharma Inc. (TYO: 4503) and Vir Biotechnology, Inc. (NASDAQ: VIR) announced a global strategic collaboration to...
Bio-Thera’s BAT4406F BLA Accepted by NMPA – Next‑Gen Anti‑CD20 mAb for Rare Disease NMOSD
Bio-Thera Solutions Inc. (SHA: 688177) announced that China’s National Medical Products Administration (NMPA) has accepted the...
MGI Tech Sells Complete Genomics to Swiss Rockets for $50M – Divests US Unit to Mitigate Geopolitical Risks
MGI Tech (SHA: 688114) announced the sale of 100% equity in its US subsidiary, Complete Genomics...