AstraZeneca and Daiichi Sankyo Submit Priority‑Review sBLA for Enhertu as First‑Line Therapy for HER2‑Positive Breast Cancer
AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) have filed a supplemental Biologics License...
Gan & Lee Secures 3 B RMB Supply Deal for Insulin Glargine in Brazil’s National PDP
Gan & Lee Pharmaceuticals Co., Ltd. (SHA: 603087) announced a landmark Technology Transfer and Supply...
MicroTech Medical Secures NMPA Approval for Equil Patch Insulin Pump in Children and Adolescents
MicroTech Medical (Hangzhou) Co., Ltd. (HKG: 2235) announced that China’s National Medical Products Administration (NMPA)...
Biogen Receives FDA Complete‑Response Letter on High‑Dose Nusinersen for SMA
Biogen Inc. (NASDAQ: BIIB) announced today that the U.S. Food & Drug Administration (FDA) has...
Eisai and Biogen Secure Australian TGA Approval for Lecanemab in Early Alzheimer’s Disease
Eisai (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) announced today that the Australian Therapeutic Goods...
XtalPi and Bio‑Sincerity Announce AI‑Robotics R&D Partnership
Shenzhen-based QuantumPharm Inc., known as Xtalpi Inc. (HKG: 2228) and Hangzhou Bio‑Sincerity (SHE: 301096) today...
Prellis Biologics and Eli Lilly Announce AI‑Driven Antibody Discovery Collaboration
Prellis Biologics, Inc. and global biopharma leader Eli Lilly & Co. (NYSE: LLY) today announced...
Fosun Kairos Secures NMPA Approval for Second CAR‑T Product, FKC889, Targeting Relapsed/Refractory B‑Cell ALL
Fosun Kairos, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196),...
Mabwell Bioscience Hits Phase II Milestone with First‑Patient Dose of 9MW3011, the Only Anti‑TMPRSS6 Monoclonal Antibody for Polycythemia Vera
Shanghai‑listed Mabwell Bioscience (SHA: 688062) announced today that its anti‑TMPRSS6 monoclonal antibody 9MW3011 (R&D code 9MW3011/DISC‑3405)...
Burning Rock Secures Japanese Approval for OncoGuide OncoScreen Plus CDx, Enabling Capivasertib Therapy
Burning Rock Ltd. (NASDAQ: BNR), a China‑based medical‑technology company, announced that its OncoGuide OncoScreen Plus CDx...
FibroGen Launches Phase 2 Dose‑Optimization Trial for CD46‑Targeted ADC FG‑3246 in Metastatic Castration‑Resistant Prostate Cancer
FibroGen, Inc. (NASDAQ: FGEN) announced today the start of a randomized, open‑label Phase 2 monotherapy trial...
DualityBio Initiates Global Phase Ia/Ib Study of ADAM9‑Targeting ADC DB‑1317
Hong Kong‑listed Duality Biologics (DoalityBio, HKG: 9606) announced that the first patient has been dosed...
Trump Administration Expands Section 232 Tariffs on Robotics, Industrial Machinery and Medical Devices
President Donald J. Trump’s administration has opened new investigations under Section 232 of the Trade Expansion Act, targeting...
Hengrui Pharma & Glenmark Partner on Trastuzumab Rezecan ADC for HER2‑Positive Lung Cancer
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced an exclusive licensing agreement with Glenmark...
Jiangsu Hengrui Receives NMPA Acceptance for SHR7280 Oral GnRH Antagonist
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products...
Johnson & Johnson Announces International Withdrawal of Linx Reflux System
US giant Johnson & Johnson (J&J, NYSE: JNJ) disclosed that it will cease sales of...
RM Bio‑Tech Secures CDE Approval for HF001 Stem‑Cell Therapy in Type 2 Diabetes
Beijing RM Bio‑Tech Co., Ltd. announced that the Center for Drug Evaluation (CDE) under the...
Jiangsu Hengrui’s Adebrelimab New Indication Accepted by NMPA for Stage II‑IIIB NSCLC
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276; HKG: 1276) announced that the National Medical Products...
Yantai Dongcheng Secures NMPA Approval for 225Ac‑LNC1011 Alpha‑Particle Radiopharmaceutical to Target Prostate Cancer
China‑based Yantai Dongcheng Pharmaceutical Group Co., Ltd. (SHE: 002675) announced that its investigational 225Ac‑LNC1011 injection...
Eli Lilly Announces $6.5 B Houston Facility to Boost Synthetic‑Medicine API Production
Eli Lilly (NYSE: LLY) announced today that it will construct a new $6.5 billion manufacturing complex...