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Systemic Mastocytosis Drug Shows Strong Phase II Efficacy, NDA Planned
Cogent Biosciences revealed positive top-line results from a Phase II registration-directed trial of bezuclastinib in indolent systemic mastocytosis, a rare immune disorder. The drug demonstrated...
Innovations and Collaborations in Genome and Cell Therapies
Global collaborations are advancing gene and cell therapies for rare diseases and cancer. The Abu Dhabi Department of Health, UCSF, and Innovative Genomics Institute partnered to build genome...
Breakthroughs in Cancer Diagnostics and Treatment Strategies
Multiple advances have emerged in cancer diagnostics and therapeutics. BostonGene and SWOG launched a biomarker-directed Phase II trial for extensive-stage small cell lung cancer, aiming to...
AI and Digital Health Funding Growth Amid Market Stabilization
Digital health startups raised $6.4 billion in the first half of 2025, driven primarily by AI-focused companies attracting significant capital amid rapid clinical adoption. Meanwhile, the digital...
FDA Approves KalVista's First Oral Treatment for Hereditary Angioedema
KalVista Pharmaceuticals secured FDA approval for Ekterly (sebetralstat), the first oral on-demand therapy to treat acute hereditary angioedema (HAE) attacks in patients aged 12 and older. The...
Cogent Biosciences Advances Systemic Mastocytosis Drug with Positive Phase II/III Data
Cogent Biosciences announced positive results from the second part of its Summit Phase II trial of bezuclastinib in non-advanced systemic mastocytosis, meeting primary and key secondary endpoints...
ProKidney’s Cell Therapy Shows Mixed Phase II Results, Positive Impact on Kidney Function Decline
ProKidney Corp. reported mixed top-line results in its Phase II REGEN-007 trial evaluating rilparencel, an autologous cell therapy for chronic kidney disease (CKD) in diabetic patients. One cohort...
FDA Staffing Crisis and Morale Collapse Threaten Regulatory Capacity
Following a government-wide hiring freeze and staff reductions affecting nearly 19% of its workforce, the FDA faces a deepening morale crisis amidst increasing political pressures and...
Precision Oncology Trial Targets Small Cell Lung Cancer Subtypes with Multiomic Biomarker Platform
BostonGene is collaborating with the SWOG Cancer Research Network on the PRISM Phase II trial for extensive-stage small cell lung cancer (ES-SCLC). The study will utilize BostonGene’s machine...
Advances in Targeted Protein Degradation Propel Next-Gen Therapeutics
Targeted protein degradation modalities, including PROTACs and molecular glues, have shown increasing maturity with clinical successes such as Arvinas and Pfizer’s vepdegestrant in breast cancer....
Novartis Gains Ground with First Malaria Drug Approved for Newborns and Infants
Novartis secured regulatory approvals in Switzerland for Coartem Baby, a novel formulation of its malaria combination therapy designed for newborns and infants. This approval addresses an unmet...
Advances in Infant Gut Microbiome Research Highlight Deficiencies Linked to Allergic and Autoimmune Risks
The My Baby Biome study, one of the largest and most diverse investigations into U.S. infant microbiomes, revealed that over 75% of participating babies exhibited key gut bacteria deficiencies...
Samsung Acquires Xealth to Integrate Digital Tools into Clinical Workflows
Samsung announced its acquisition of Xealth, a digital health platform that facilitates the integration of digital health tools into hospital workflows. The move reflects the accelerating demand...
New AI-Powered Platform Enhances Protein Engineering Through Structural and Evolutionary Insights
Researchers developed AiCE, an innovative AI approach that integrates structural and evolutionary constraints into protein engineering models. This method enables accelerated and efficient protein...
AI-Driven Protein Engineering Boosts Research Efficiency
Researchers have developed AiCE, an AI-informed method that integrates structural and evolutionary constraints to accelerate protein engineering. This innovation streamlines the rapid evolution of...
Regulatory Update: FDA Approvals and Industry Challenges
The FDA has recently approved several notable drugs including KalVista Pharmaceuticals' oral treatment for hereditary angioedema, Dizal Pharmaceutical’s sunvozertinib for metastatic non-small-cell...
Cell Therapy Advances and Clinical Developments
Clinical progress continues in cell therapy with promising data from EsoBiotec’s in vivo CAR-T therapy showing responses in multiple myeloma patients, and Australian researchers developing...
Biotech M&A Activity Accelerates Amidst Market Challenges
Concentra Biosciences extended its acquisition spree with a buyout deal for struggling Cargo Therapeutics, following purchases of multiple other biotechs facing operational setbacks. Quanterix...
Malaria Treatment Expanded for Newborns and Infants
Novartis has gained regulatory approval in Switzerland for Coartem Baby, becoming the first to offer a malaria treatment tailored to newborns and young infants. The new formulation includes a dose...
Advances in Precision Oncology and Biomarker-Guided Trials
BostonGene and the SWOG Cancer Research Network are launching a Phase II trial leveraging multiomic platforms to identify molecular subtypes of extensive-stage small cell lung cancer, aiming to...