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Legal Challenges Target HHS Over COVID-19 Vaccine Recommendation Changes
Several medical groups and a pregnant physician have filed lawsuits against HHS Secretary Robert F. Kennedy Jr., contesting his directive to alter COVID-19 vaccine recommendations for healthy...
KalVista and FDA Navigate Approval and Review Delays for HAE Drug Ekterly
KalVista’s path to FDA approval for Ekterly included unexpected review delays attributed to agency resource limitations. The company described regulatory discussions with FDA reviewers as thorough...
Biotech Partnerships Leverage AI and Human Models for Heart Failure Drug Discovery
HeartBeat Bio of Austria and Germany’s BiotxAI established a strategic partnership to identify and validate genetic targets for heart failure therapy. Using BiotxAI’s Mendelian randomization...
Feng Zhang Highlights CRISPR Diversity and Delivery Innovations for Human Health
In a keynote at the GEN virtual summit, Feng Zhang, Broad Institute and Howard Hughes Medical Institute investigator, presented breakthroughs from his lab including novel gene editing delivery...
Non-Small Cell Lung Cancer Study Links Steroids to Reduced Immunotherapy Efficacy
A study led by Keck Medicine USC revealed that corticosteroid use among non-small cell lung cancer (NSCLC) patients impairs the effectiveness of immune checkpoint inhibitors (ICI). High-dose...
Legal Challenge Over HHS Covid-19 Vaccine Policy Shift
Six medical groups alongside a pregnant physician have filed a lawsuit against Health and Human Services Secretary Robert F. Kennedy Jr. challenging his changes to federal COVID-19 vaccine...
Gene Therapy Shows Promise in Inherited Hearing Loss Across Ages
A trial in China involving an adeno-associated virus (AAV) based gene therapy delivering the OTOF gene demonstrated hearing improvements in ten participants aged 1.5 to 23.9 years with autosomal...
Apogee's Anti-IL-13 Drug Shows Breakthrough in Atopic Dermatitis
Apogee Therapeutics announced positive Phase 2 data for APG777, an anti-IL-13 monoclonal antibody that significantly reduced symptoms of moderate-to-severe atopic dermatitis compared to placebo....
FDA Approves KalVista’s Oral Drug for Rare Swelling Disorder After Review Delay
The FDA approved KalVista Pharmaceuticals’ pill Ekterly (sebetralstat) to treat acute hereditary angioedema attacks in patients aged 12 and older. This approval comes after a brief delay...
Cogent Biosciences Advances Mastocytosis Therapy With Positive Trial Data
Cogent Biosciences reported statistically significant improvements in non-advanced systemic mastocytosis symptoms from their Phase 2 and Phase 3 trials of bezuclastinib, a KIT D816V tyrosine...
Advances and Collaborations in AI-Driven Drug Discovery and Diagnostics
Artificial intelligence is increasingly integral to preclinical drug discovery, with new centers such as Mount Sinai’s AI Small Molecule Drug Discovery Center providing cross-sector research and...
Innovative Single-Cell and Spatial Biology Technologies Expand Research Capabilities
Single-cell RNA sequencing and related technologies continue their rapid growth, enabling refined understanding of cellular heterogeneity across tissues. The Human Cell Atlas project and others...
Novel Genome Editing and Base Editing Techniques Enhance Precision Therapeutics
Emerging genome editing technologies continue to improve specificity in nucleotide modification without double-strand breaks. Recent developments include the evolution of cytosine base editors...
Biotech Financing and Market Trends Reflect Sector Adjustment Post-Pandemic
Biopharma fundraising totaled $28.7 billion in the first half of 2025, down 59% from 2024 but aligning with levels from recent years prior to record highs. Notable financings include Quantum-Si...
Cogent Biosciences Advances with Rare Disease Drug: Phase 3 Success and FDA Filing Likely
Cogent Biosciences announced positive Phase 3 trial results for its drug bezuclastinib targeting indolent systemic mastocytosis, an immune disorder that causes allergic-like and systemic symptoms....
FDA Approvals and Industry Challenges: KalVista’s HAE Drug Gains Clearance Amid Agency Morale Crisis
KalVista Pharmaceuticals received FDA approval for Ekterly (sebetralstat), an orally-delivered treatment for hereditary angioedema (HAE), marking a significant entry on the rare disease market....
Clinical Trial Setbacks: Jasper Therapeutics Faces Data Issues and Stock Drop
Jasper Therapeutics disclosed a compromised drug lot that affected data integrity in a Phase 1b/2a trial for its leading urticaria treatment, briquilimab. The issue has prompted uncertainty about...
Apogee Therapeutics Advances Atopic Dermatitis Pipeline with IL-13 Antibody Showing Promise
Apogee Therapeutics reported positive Phase 2 results for APG777, an anti-IL-13 antibody for atopic dermatitis, demonstrating a 71% reduction in disease severity over placebo and comparable...
Viome and Microsoft Partner to Integrate AI-Powered RNA Diagnostics for Preventive Healthcare
Viome Life Sciences announced a collaboration with Microsoft to deploy AI-enhanced, RNA-based molecular diagnostics for personalized nutrition and proactive healthcare. The partnership leverages...
Genomics Collaboration Set to Advance Early Diagnosis and Gene Editing Treatments in Abu Dhabi
The Abu Dhabi Department of Health has partnered with UCSF and the Innovative Genomics Institute to establish genome medicine centers integrating clinical care and CRISPR gene-editing...