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Novel Protein and RNA Therapeutics Gain Momentum
RNA therapeutics and epitranscriptomics are emerging as key areas in medicine, offering transient and precise modulation of gene expression with less arduous regulatory pathways. Platforms such as...
Legal Challenges Arise Around Changes to US COVID-19 Vaccine Policy
Multiple medical groups, including the American Academy of Pediatrics, have filed lawsuits against Health and Human Services Secretary Robert F. Kennedy Jr. over his unilateral changes to COVID-19...
Breakthrough Gene Therapy Restores Hearing Across Age Spectrum
A gene therapy trial in China tested adeno-associated virus (AAV)-mediated delivery of a functional OTOF gene for autosomal recessive deafness 9 across children and young adults. Ten participants...
Kalvista’s Oral Drug Ekterly Joins Market After FDA Delay
Kalvista Pharmaceuticals has secured FDA approval for Ekterly (sebetralstat), an oral therapy to treat hereditary angioedema (HAE) attacks in patients aged 12 and older. After a delayed decision...
Cogent Biosciences Advances Mastocytosis Drug With Positive Phase 3 Data
Cogent Biosciences reported robust Phase 3 trial results for bezuclastinib, targeting indolent systemic mastocytosis (SM), a chronic immune disorder. The study demonstrated statistically...
Apogee Therapeutics’ Atopic Dermatitis Drug Shows Superior Phase 2 Results
Apogee Therapeutics announced that its experimental anti-IL-13 antibody APG777 significantly reduced symptoms of moderate-to-severe atopic dermatitis in a Phase 2 trial. The drug achieved a 71%...
Single-Cell Genomics Accelerates With Cheaper Sequencing and Expanding Data
Single-cell RNA sequencing (scRNA-seq) has matured into a cornerstone technology enabling detailed cellular analysis across tissues. The International Human Cell Atlas (HCA) Consortium is near...
Digital Health Financing Shows AI Dominance and Market Maturity in 2025
Digital health startups garnered $6.4 billion in funding during H1 2025, led largely by AI-focused companies driving adoption in healthcare providers. The sector witnessed notable IPOs and...
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...