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Merck’s sBLA for ENFLONSIA™ Accepted by FDA for Expanded RSV Prophylaxis in High-Risk Infants Under Two for Second Season
Merck.com (News releases) USA Overview Merck announced that the U.S. FDA has accepted its supplemental Biologics License Application (sBLA) for ENFLONSIA™ (clesrovimab-cfor) to expand its Respiratory Syncytial Virus (RSV) lower respirato... -
Merck Achieves Robust Q2 2026 Performance, Upgrades Full-Year Guidance, and Empatran Secures FDA Breakthrough Therapy Designation for Lupus
Merck USA Overview Merck reported strong second-quarter 2026 financial results and consequently upgraded its full-year guidance, bolstered by the U.S. FDA's Breakthrough Therapy Designation for Empatran in July. Empatran, developed for l... -
Researchers Uncover Key Cellular Uptake Pathway for Antisense Therapies, Paving Way for Enhanced Efficacy
ecancer Global Overview Researchers have made a significant discovery, identifying the crucial intracellular uptake pathway for antisense oligonucleotides (ASOs), a therapeutic approach to halt aberrant protein production in various dise... -
AI Generative Biology Transforms Drug Discovery: Multiple AI-Designed Drugs Enter Clinics, One in Late-Stage Development
SynBioBeta USA Overview AI-driven generative biology is rapidly transitioning from laboratory promise to human clinical trials, fundamentally reshaping the drug discovery paradigm. At the AI4 2026 conference, biotech leaders highlighted ... -
Exosome Therapeutics Advancing in Neurodegenerative and Oncology Fields, Eyeing Blood-Brain Barrier Penetration
BioInformant Global Overview Exosome therapeutics are showing significant promise in 2026, particularly for neurodegenerative diseases due to their unique ability to cross the blood-brain barrier, with clinical development also progressi... -
FDA Grants Accelerated Approval to BMS’s CELMoD Zenbexus in Quadruple Therapy for Relapsed/Refractory Multiple Myeloma
Drugs.com, FDA.gov USA Overview The U.S. FDA has granted accelerated approval to Bristol Myers Squibb's cereblon E3 ligase modulating agent (CELMoD) Zenbexus (iberdomide) in combination with daratumumab, hyaluronidase-fihj, and dexametha... -
FDA Grants Accelerated Approval for Oncoytic Virus Tudriqev + Nivolumab in Unresectable Advanced Melanoma
Drugs.com USA Overview The U.S. FDA has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic virus therapy, in combination with nivolumab for the treatment of unresectable advanced c... -
Breakthrough: EU Approves Oral BTK Inhibitor Tolebrutinib as First Disability-Targeting Therapy for Nonrelapsing SPMS
NeurologyLive Europe Overview The European Commission has approved Sanofi's oral, brain-penetrant Bruton's tyrosine kinase (BTK) inhibitor, tolebrutinib (Cenrifki), for nonrelapsing secondary progressive multiple sclerosis (SPMS). This a... -
AI-Enabled Assay Discovers 31 Anti-Aging Compounds from 2,782 FDA-Approved Drugs, Extending C. elegans Lifespan
bioRxiv International Overview A bioRxiv preprint describes an open-source AI-enabled screening platform using C. elegans to rapidly identify geroprotective drugs. The platform screened 2,782 FDA-approved compounds, identifying 31 agents... -
EMA Panel Backs Incyte’s Opzelura: Topical JAK Inhibitor Promises Rapid Relief for Moderate Atopic Dermatitis
Medical Update Online Europe Overview The European Medicines Agency's (EMA) CHMP has issued a positive opinion for Incyte's Opzelura (ruxolitinib) cream, recommending its approval for adult patients with moderate atopic dermatitis unresp...
