D3 Bio Secures Breakthrough Therapy Designation for Elisrasib – Next-Generation KRAS G12C Inhibitor for First-Line NSCLC
D3 Bio announced that China’s Center for Drug Evaluation (CDE) of the National Medical Products...
Drug
Cloudbreak Pharma Submits FDA IND for CBT-358, Novel SFA+ Technology-Based Dry Eye Treatment
Cloudbreak Pharma Inc. (HKG: 2592) announced it has submitted an Investigational New Drug (IND) application...
Henlius Biotech’s PD-1 Inhibitor Hetronifly Receives CHMP Recommendation for Squamous NSCLC in EU
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the European Medicines Agency’s Committee for Medicinal...
Boehringer Ingelheim’s Ofev Receives CHMP Endorsement for Idiopathic and Progressive Pulmonary Fibrosis
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a...
Regeneron’s Otarmeni Gene Therapy Accepted for EMA Accelerated Review as First Potential Treatment for OTOF-Related Hearing Loss
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the European Medicines Agency (EMA) has accepted for...
Everest Medicines Secures South Korean Approval for Velsipity in Ulcerative Colitis Following Pfizer-Arena Legacy
Everest Medicines (HKG: 1952) announced it has received marketing approval in South Korea for Velsipity...
Jiangsu Chia Tai Tianqing Secures NMPA Priority Review for LM-302 ADC in CLDN18.2-Positive Gastric Cancer
Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a subsidiary of Sino Biopharmaceutical Ltd (HKG:...
Lupin Secures NMPA Approval for Oseltamivir Phosphate in China Through Yabao Pharmaceuticals Partnership
Lupin Limited (NSE: LUPIN) announced that China’s National Medical Products Administration (NMPA) has approved its...
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:...
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 (NYSE: 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...