Gilead’s Seladelpar Wins China Hainan Approval for PBC Treatment
Gilead Sciences (NASDAQ: GILD) announced that Seladelpar (marketed as Livdelzi), a potent and selective PPARδ...
Alphamab JSKN003 ADC FDA Breakthrough Therapy Targets Ovarian Cancer
Alphamab Oncology (HKG: 9966) announced that its independently developed HER2‑targeting biparatopic antibody‑drug conjugate (ADC), JSKN003,...
CDE Reference Standards 101st Batch Seeks Public Feedback
China’s Center for Drug Evaluation (CDE) announced it is seeking public feedback on the 101st...
Jemincare JMX-2005 PAD Injection Secures NMPA Clinical Trial Approval
Jiangxi Jemincare Group (SHA: 603222) announced that its Class 2.2 and Class 2.4 new drug application for...
J&J TREMFYA Pediatric Psoriasis EC Approval Targets First IL-23 Indication
Johnson & Johnson (J&J, NYSE: JNJ) announced that the European Commission (EC) has extended the...
Takeda Zasocitinib TYK2 Phase III Shows Positive Psoriasis Results
Takeda Pharmaceutical Company (TYO: 4502, NYSE: TAK) announced positive topline results from two pivotal Phase III...
Lilly Imlunestrant Breast-Cancer EMBER-3 Shows 38% Risk Reduction
Eli Lilly (NYSE: LLY) announced updated results from the Phase III EMBER‑3 clinical trial evaluating its...
IVIEW GVB-2001 Gene Therapy Treats First POAG Patient Successfully
IVIEW Therapeutics Inc. announced the successful treatment of the first patient with primary open-angle glaucoma...
Novartis MSD Sanofi TrumpRx Deal Targets Medicaid Pricing
Novartis (NYSE: NVS), MSD (NYSE: MRK), and Sanofi (NASDAQ: SNY) announced partnerships with the U.S....
Novabio’s Treg Therapy NP001 Doses First ALS Patient in China Trial
Novabio Therapeutics, a China‑based clinical‑stage biotech, announced the successful completion of first patient dosing in...
Grand Pharmaceutical’s TLX591‑CDx RDC Wins China Phase III for Prostate Cancer Diagnosis
Grand Pharmaceutical Group Limited (HKG: 0512) announced that its China‑based Phase III clinical trial for TLX591‑CDx...
MiniMed Diabetes Files for IPO, Seeking Nasdaq Listing as MMED
Medtronic plc (NYSE: MDT) announced that its diabetes business, which will operate under the name MiniMed,...
Simcere Zaiming Licenses ADC SIM0613 to Ipsen in $1.06 Billion Deal
Simcere Pharmaceutical Group Limited’s (HKG: 2096) subsidiary Simcere Zaiming entered into an exclusive global licensing...
Merck’s Pimicotinib Wins China Approval as First Class 1 Therapy for TGCT
Merck KGaA (ETR: MRK) announced that China’s National Medical Products Administration (NMPA) granted priority review approval...
GSK’s Nucala Wins China Approval as First IL‑5 Biologic for COPD
GlaxoSmithKline (GSK, NYSE: GSK) China announced that China’s National Medical Products Administration (NMPA) approved Nucala...
EPI-003 Wins FDA IND as First LNP Epigenetic Therapy for Hepatitis B
Epigenic Therapeutics (Shanghai) Biotechnology Co., Ltd., a clinical‑stage biotech focused on epigenetic modulation therapies, announced...
SanegeneBio’s INHBE siRNA Wins China IND for Obesity as First RNAi Target
SanegeneBio, a clinical‑stage RNAi therapeutics company, announced that China’s National Medical Products Administration (NMPA) approved...
Fosun Pharma Partners with Clavis Bio in $362.5M Strategic Collaboration
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (SHA: 600196, HKG: 2196) announced a strategic collaboration with...
BeOne Medicines Wins FDA Fast Track for GPC3 Bispecific in Liver Cancer
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced that the U.S. Food and Drug...
BeOne Medicines Names Dual Presidents in Leadership Overhaul
BeOne Medicines Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235) announced a leadership restructuring, appointing Dr. Lai...