Gilead Sciences Secures FDA Accelerated Approval for Hepcludex as First US Treatment for Hepatitis Delta Virus
The U.S. Food and Drug Administration (FDA) granted accelerated approval to Gilead Sciences, Inc. (NASDAQ:...
Drug
AbbVie Secures CHMP Positive Opinion for MAVIRET in Acute Hepatitis C Treatment Across All Age Groups
AbbVie Inc. (NYSE: ABBV) announced that the Committee for Medicinal Products for Human Use (CHMP)...
Daiichi Sankyo, AstraZeneca Secure FDA Approval for Datroway in Triple-Negative Breast Cancer After Phase III TROPION-Breast02 Success
Daiichi Sankyo Company, Limited (TYO: 4568) and AstraZeneca PLC (NASDAQ: AZN) announced U.S. Food and...
Novo Nordisk Secures CHMP Positive Opinion for Wegovy 7.2 mg Single-Dose Pen and Oral Semaglutide in EU Obesity Treatment
Novo Nordisk A/S (NYSE: NVO) announced that the Committee for Medicinal Products for Human Use...
Biogen, Denali Terminate Parkinson’s Drug BIIB122 After Phase IIb LUMA Study Failure
Biogen Inc. (NASDAQ: BIIB) and Denali Therapeutics Inc. (NASDAQ: DNLI) jointly announced the termination of...
Junshi Biosciences Secures NMPA Approval for Loqtorzi Combination Therapy in HER2-Expressing Urothelial Carcinoma
Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) announced that China’s National Medical Products...
Shanghai Henlius Biotech Secures Australian TGA Approval for Phase I Trial of HLX3902 Trispecific T-Cell Engager in Prostate Cancer
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that Australia’s Therapeutic Goods Administration (TGA) has granted...
Shanghai Henlius Biotech Secures NMPA Approval for Phase I Trial of HLX48 Bispecific ADC in Advanced Solid Tumors
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that China’s National Medical Products Administration (NMPA) has...
Sino Biopharmaceutical Presents Positive Phase III and II Data for M701 Bispecific Antibody at ASCO 2026
Sino Biopharmaceutical Ltd (HKG: 1177) announced positive results from its Phase III and Phase II...
Qyuns Therapeutics and Huadong Medicine Secure NMPA Approval for Stelara Biosimilar HDM3001-2/QX001S in Crohn’s Disease
Qyuns Therapeutics (HKG: 2509) announced that HDM3001-2/QX001S, a biosimilar to Johnson & Johnson’s autoimmune therapy...
3D Medicines Enrolls First Patient in Pivotal Phase III Trial of Envafolimab for Resectable NSCLC
3D Medicines (HKG: 1244) announced the enrollment of the first patient in a Phase III...
Allergan Aesthetics Secures CHMP Positive Opinion for Boey (TrenibotulinumtoxinE) in Glabellar Lines Treatment Across European Economic Area
Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced that the European Medicines Agency’s (EMA) Committee...
Lupeng Pharma Enrolls First Patient in Global Phase 3 ROCKET-CLL Trial of Fourth-Gen BTK Inhibitor Rocbrutinib vs. Pirtobrutinib
Lupeng Pharmaceutical Ltd. announced the enrollment of the first patient in its global Phase 3...
Eli Lilly’s Retatrutide Delivers Breakthrough Weight Loss Results in Phase 3 TRIUMPH-1 Trial for Obesity Treatment
Eli Lilly and Company (NYSE: LLY) announced positive topline results from the TRIUMPH-1 Phase 3...
Merck KGaA Launches Phase III PROCEADE-CRC-03 Trial for First-in-Class CEACAM5 ADC Precemtabart Tocentecan in Metastatic Colorectal Cancer
Merck KGaA (ETR: MRK) announced the initiation of the Phase III PROCEADE-CRC-03 study, evaluating the...
Astellas and MSD’s PADCEV-Keytruda Combination Receives Positive CHMP Opinion for Muscle-Invasive Bladder Cancer in EU
Astellas Pharma Inc. (TYO: 4503) announced that the Committee for Medicinal Products for Human Use...
Hansoh Pharma’s HS-10504 Receives NMPA Breakthrough Therapy Designation for Fourth-Generation EGFR Inhibitor in Resistant NSCLC
Hansoh Pharmaceutical Group Co., Ltd. (HKG: 3692) announced that China’s Center for Drug Evaluation (CDE)...
Bayer’s Kerendia Receives FDA Priority Review for Expanded Indication in Type 1 Diabetes-Associated Chronic Kidney Disease
Bayer AG (ETR: BAYN) announced that the U.S. Food and Drug Administration (FDA) has accepted...
Yangtze River Pharma Secures NMPA Approval for Fazamorexant – Next-Generation DORA for Insomnia Treatment
Yangtze River Pharmaceutical Group (YRPG) announced that China’s National Medical Products Administration (NMPA) has granted...
Boehringer Ingelheim and Sino Biopharmaceutical Secure NMPA Conditional Approval for Hernexeos in First-Line HER2-Mutant NSCLC With 76% Response Rate
Boehringer Ingelheim (BI) and Sino Biopharmaceutical Ltd (HKG: 1177) jointly announced that Hernexeos (zongertinib) has...