China’s CDE Releases 106th Batch of Chemical Generic Reference Preparations with 27 New Specifications and Updated Guidelines
The Center for Drug Evaluation (CDE) under China’s National Medical Products Administration has published the...
FDA Extends Review Timeline for Sanofi’s Sarclisa Subcutaneous Formulation by Three Months; New Decision Date Set for July 23, 2026
The U.S. Food and Drug Administration (FDA) has extended the target action date for its...
NMPA Suspends Colchicine API Imports from Indian Manufacturers Alkaloids Bioactives and Alchem International Over Change Management Violations
China’s National Medical Products Administration (NMPA) has announced the immediate suspension of imports of colchicine...
Merck’s Idvynso Gains FDA Approval as Novel Dual-Drug HIV Treatment
Merck & Co., Inc. (MSD, NYSE: MRK) announced that the U.S. Food and Drug Administration...
Boji Medical Sells Fluconazole Ear Drops Technology to Chengdu Pusch for $2M
Boji Medical Technology Co., Ltd. (SHE: 300404), a Chinese clinical research organization (CRO), has entered...
Roche’s Fenebrutinib Slashes MS Relapse Rates by Over 50% in Phase III Trials
Roche AG (SWX: ROP, OTCMKTS: RHHBY) announced that its investigational non-covalent Bruton’s tyrosine kinase (BTK)...
Novabio Therapeutics and OBiO Tech Strengthen Partnership to Advance Treg Cell Therapies for Neurodegenerative Diseases
Novabio Therapeutics and OBiO Tech, Inc. (SHA: 688238) have expanded their strategic collaboration to accelerate...
Gan & Lee’s Nectin-4 ADC GLR1059 Clears Regulatory Hurdle for Solid Tumor Trials
Gan & Lee Pharmaceuticals Co., Ltd. (SHA: 603087) announced it has received approval from China’s...
Danaher Q1 Earnings Beat Expectations as Bioprocessing Strength Offsets Cepheid Weakness
Danaher Corporation (NYSE: DHR) reported first-quarter 2026 revenues of $6.0 billion, up 3.5% year-over-year, with...
Leads Biolabs Enrolls First Patient in Phase II Trial for Gastric Cancer Drug Opamtistomig
Nanjing Leads Biolabs Co., Ltd. (HKG: 9887) announced the first patient enrollment in a Phase...
Roche’s Gazyva Gains FDA Review Acceptance for Systemic Lupus Erythematosus Treatment
Roche AG (SWX: ROP, OTCMKTS: RHHBY) announced that the U.S. Food and Drug Administration (FDA)...
InxMed Limited Files for Hong Kong IPO with Near-Commercial FAK Inhibitor Ifebemtinib
InxMed Limited, a China-based late-stage clinical biotechnology company, has filed a prospectus for an initial...
Daiichi Sankyo and AstraZeneca Launch Datroway ADC in China for HR-Positive, HER2-Negative Breast Cancer
Daiichi Sankyo Co., Ltd. (TYO: 4568) and AstraZeneca plc (NYSE: AZN) announced the commercial launch...
Merck and Eisai’s LITESPARK-012 Trial Fails to Meet Primary Endpoints in Advanced Kidney Cancer
Merck & Co., Inc. (MSD, NYSE: MRK) and Eisai Co., Ltd. (TYO: 4523) announced that...
AstraZeneca’s Ultomiris Shows Significant Proteinuria Reduction in Phase III IgA Nephropathy Trial
AstraZeneca plc (NYSE: AZN) announced positive results from a pre-specified interim analysis of the Phase...
China’s Drug Quality Control System Shows 99.5% Compliance Rate in 2025 NMPA Report
The National Medical Products Administration (NMPA) has released its National Drug Sampling Inspection Annual Report...
NeuroGen Pharma Secures Exclusive China Rights to Teva’s Ajovy – World’s First Dual-Indication CGRP Antagonist for Migraine Prevention
NeuroGen Pharma announced a strategic licensing agreement with Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), securing...
Eli Lilly to Acquire Kelonia Therapeutics for $7 Billion to Secure In Vivo CAR-T Platform Targeting Multiple Myeloma
Eli Lilly and Company (NYSE: LLY) has agreed to acquire Kelonia Therapeutics, a clinical-stage biotechnology...
CSPC’s Albumin-Bound Sirolimus (HB1901) Meets Primary Endpoint in Phase Ib/III Trial for Rare PEComa, Reinforcing Breakthrough Therapy Status
CSPC Pharmaceutical Group Ltd. (HKG: 1093) announced that its pivotal Phase Ib/III clinical trial of...
AI Healthtech Firm WeiMai Files for Hong Kong IPO, Touting CareAI Platform and Leadership in Hospital-Linked Disease Management
WeiMai Inc., an artificial intelligence–driven disease management company based in Hangzhou, has filed its initial...