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Medical Groups Sue HHS Secretary Over Changes to COVID-19 Vaccine Policy
Six medical organizations and a pregnant physician filed a lawsuit against Health and Human Services Secretary Robert F. Kennedy Jr., challenging recent federal changes that removed COVID-19...
AI Transforms Protein and Drug Engineering
Artificial intelligence is rapidly reshaping protein engineering and drug development. University of Copenhagen secured a $109 million grant from Novo Nordisk Foundation to establish a protein...
Actithera Advances Radiopharmaceutical Cancer Drugs with $75M Funding
Actithera, a radiopharmaceutical startup with bases in Oslo and Cambridge, has raised nearly $76 million in Series A funding to develop experimental cancer drugs targeting fibroblast activation...
FDA Approvals and Regulatory Updates in Biotech and Med-Tech
Recent months have seen several key regulatory developments. The FDA granted accelerated approval to KalVista’s oral drug Ekterly for hereditary angioedema, marking a first oral option for this...
Progress and Setbacks in Duchenne Muscular Dystrophy Drug Trials
Taiho Pharmaceutical reported the failure of its phase III trial for pizuglanstat, an experimental therapy for Duchenne muscular dystrophy (DMD). The study did not meet its primary endpoint...
Kidney Disease Cell Therapy Shows Promise Despite Mixed Phase 2 Results
ProKidney announced mixed phase 2 trial outcomes for rilparencel, its autologous cell therapy targeting chronic kidney disease (CKD). One patient cohort receiving two injections demonstrated a...
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...