Get the Daily Brief
Latest Biotech News
KalVista’s Oral Drug Approved by FDA for Hereditary Angioedema
KalVista Pharmaceuticals received FDA approval for Ekterly (sebetralstat), the first oral on-demand treatment for hereditary angioedema (HAE) attacks in patients aged 12 and older. This approval...
Cogent Biosciences’ Bezuclastinib Advances in Mastocytosis
Cogent Biosciences reported positive Phase 3 data for bezuclastinib in non-advanced systemic mastocytosis (SM), demonstrating statistically significant improvements in patient-reported symptoms...
Apogee Therapeutics’ IL-13 Antibody Shows Promise in Atopic Dermatitis
Apogee Therapeutics’ APG777 antibody demonstrated significant improvement in atopic dermatitis symptoms in Phase 2 trials, reducing eczema severity by 71% compared to placebo. Its longer half-life...
FDA Faces Staffing Shortages and Morale Challenges
The FDA is undergoing a significant workforce reduction, losing nearly 20% of its staff due to recent layoffs and continued departures. Agency employees report low morale fueled by political...
Major US Biopharma Financing and Funding Trends in 2025
Biopharma financing for the first half of 2025 totaled $28.7 billion, marking a 59% decline compared with 2024 yet aligning with typical pre-pandemic levels. June 2025 saw a rebound with $7.38...
Advances in Single-Cell Genomics and AI Applications in Biotech
Single-cell RNA sequencing continues to expand, enabling detailed cellular atlases and understanding of disease heterogeneity, with international consortia like the Human Cell Atlas driving large...
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...