China Medical System Secures NMPA Approval for CMS-D001 TYK2 Inhibitor in Ulcerative Colitis and Crohn’s Disease
China Medical System Holdings Limited (CMS, HKG: 0867) announced it has received clinical trial authorization...
Drug
Eli Lilly Reports Positive Phase 1b Results for VERVE-102 Base Editing Therapy with Sustained LDL-C Reductions Up to 18 Months
Eli Lilly and Company (NYSE: LLY) announced positive interim results from the Phase 1b Heart-2...
Pierre Fabre Secures EU Recommendation for Braftovi Combo in First-Line BRAF V600E-Mutant Metastatic Colorectal Cancer
Pierre Fabre Laboratories announced that the European Medicines Agency’s Committee for Medicinal Products for Human...
OTR Therapeutics Secures NMPA Approval for Phase Ib/II Trial of OTR-8100 – Best-in-Class Small Molecule Inhibitor for Malignant Tumors
OTR Therapeutics announced that China’s National Medical Products Administration (NMPA) has granted approval to initiate...
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...
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...