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...
Company
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,...
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),...
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...
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...
Junshi Biosciences Partners with Antengene on Cancer Combination – JS207 PD‑1/VEGF Bispecific Plus ATG‑037 CD73 Inhibitor
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) announced a strategic collaboration with Antengene Corporation Limited...
AbbVie Invests $380M in Illinois API Manufacturing – AI‑Enabled Facilities for Neuroscience and Obesity Drugs
AbbVie (NYSE: ABBV) announced a USD 380 million investment to build two new active pharmaceutical ingredient (API) manufacturing...