Drug Discovery & DDS– category –
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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... -
BMS’s First CELMoD Therapy ZENBEXUS™ Receives Accelerated FDA Approval in Combination with Daratumumab for Multiple Myeloma, Including Early Relapse Patients
Bristol Myers Squibb USA Overview The U.S. FDA granted accelerated approval to Bristol Myers Squibb's first Cereblon E3 ligase modulator (CELMoD) therapy, ZENBEXUS™ (iberdomide), in combination with daratumumab, hyaluronidase-fihj, and d... -
FDA Grants Accelerated Approval to Replimune’s Onco-Viral Therapy Tudriqev in Combination with Nivolumab for Advanced Melanoma, Offering New Treatment Option
U.S. Food and Drug Administration USA Overview The U.S. FDA granted accelerated approval to Replimune, Inc.'s oncolytic viral therapy Tudriqev (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adult patients with advance... -
Ractigen Therapeutics Completes Phase II Enrollment for SOD1-ALS siRNA RAG-17; LiCO Therapy RAG-18 for DMD Receives Rare Pediatric Disease Designation
Facebook China Overview Ractigen Therapeutics announced the completion of patient enrollment and first dosing in its Phase II clinical trial for RAG-17, an investigational siRNA therapy for SOD1-mutated amyotrophic lateral sclerosis (ALS... -
Gilead Report Highlights RNA Therapeutic Progress: GSK/Ionis HBV ASO Shows Positive Phase 3, Novartis FSHD siRNA Promising Early Data
The Bio Report USA Overview A Gilead report underscores significant advancements in RNA therapeutic clinical trials, with GSK/Ionis's beoprovirsen, an ASO targeting HBV, demonstrating positive Phase 3 results. Novartis's siRNA therapy, D... -
Denali Therapeutics Advances DNL628 (MAPT-Targeting ASO) for Neurodegenerative Diseases, DNL593 for GRN FTD Granted Orphan Drug Designation
Seeking Alpha USA Overview Denali Therapeutics is progressing DNL628, an intravenously administered ASO designed to reduce tau by targeting MAPT, with initial Phase 1b biomarker data expected in H1 2027 from its TransportVehicle platform... -
SynaptixBio Accelerates Regulatory Pathway for Ultra-Rare ASO Drugs, Expanding Therapeutic Potential of TUBB4A Mutant Silencers
Advancing RNA USA Overview SynaptixBio is effectively navigating the regulatory landscape for ultra-rare antisense oligonucleotide (ASO) drugs, securing Orphan Drug and Rare Pediatric Disease designations in collaboration with the FDA, E...
