FDA Expands Sanofi’s Tzield Approval to Children as Young as One Year Old for Type 1 Diabetes Prevention
The U.S. Food and Drug Administration (FDA) has approved a supplemental biologics license application for...
Boston Scientific Reports Strong Q1 2026 Results with 9.4% Net Sales Growth; Cardiovascular Segment Leads Performance
Boston Scientific Corporation (NYSE: BSX) has released its first quarter 2026 financial results, reporting group...
European Commission Grants Conditional Approval to Ipsen’s Ojemda (Tovorafenib) for Pediatric Low-Grade Glioma with BRAF Alterations
Ipsen S.A. (EPA: IPN, OTCMKTS: IPSEY) announced on April 22, 2026, that the European Commission...
Johnson & Johnson Secures CE Mark for Advanced ETHICON 4000 Surgical Stapler with Proprietary 3D Stapling Technology
Johnson & Johnson (J&J, NYSE: JNJ) announced on April 22, 2026, that it has received...
FDA Approves Sanofi-Regeneron’s Dupilumab for Pediatric Chronic Spontaneous Urticaria in Children Aged 2–11 Years
The U.S. Food and Drug Administration (FDA) has granted approval to Sanofi (NASDAQ: SNY) and...
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...