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KalVista’s Oral Drug Ekterly Gains FDA Nod for Rare Swelling Disorder
KalVista Pharmaceuticals secured FDA approval for Ekterly, an oral treatment for hereditary angioedema (HAE) attacks in patients aged 12 and above. The drug, sebetralstat, offers a convenient...
Cogent Biosciences Advances Mastocytosis Therapy With Phase 2 and 3 Data
Cogent Biosciences reported positive Phase 2 and Phase 3 clinical trial results for bezuclastinib, a tyrosine kinase inhibitor targeting non-advanced systemic mastocytosis (SM). The drug...
Apogee Therapeutics Shows Promise With Long-Acting IL-13 Antibody in Eczema
Apogee Therapeutics announced compelling Phase 2 data for APG777, its anti-IL-13 antibody targeting atopic dermatitis. The drug significantly reduced disease severity versus placebo and...
BostonGene and SWOG Launch Precision Trial Targeting Small Cell Lung Cancer
BostonGene and the SWOG Cancer Research Network initiated the S2409 PRISM Phase 2 clinical trial for extensive-stage small cell lung cancer (ES-SCLC). Utilizing BostonGene's machine...
Concentra Biosciences Accelerates Biotech Acquisitions With Cargo Therapeutics Buy
Concentra Biosciences, a serial acquirer of struggling biotech firms, has finalized the acquisition of Cargo Therapeutics amid the latter's financial distress and clinical setbacks. The deal...
AI Enables Discovery of Sperm Cells in 'Sterile' Samples, Leading to Pregnancy
Columbia University researchers adapted astrophysics-based AI algorithms to detect sperm cells missed by manual techniques in samples previously deemed sterile. The system, STAR, scanned millions...
Viome Teams With Microsoft to Advance AI-Driven RNA Diagnostics for Preventive Care
Viome Life Sciences partnered with Microsoft to leverage Azure infrastructure for AI-powered RNA-based molecular diagnostics. The collaboration integrates human and microbial gene expression data...
Microbial Carbon Capture via Bacillus megaterium Offers Clean Mineralization Pathway
Researchers from EPFL and partners revealed that the soil bacterium Bacillus megaterium can mineralize CO₂ into high-purity calcium carbonate under elevated CO₂ concentrations, bypassing...
Cytiva Expands Globally With $1.6 Billion in Manufacturing Projects
Cytiva, a Danaher unit specializing in biopharma tools and services, announced completion and growth of $1.6 billion in global expansion initiatives across the U.S., Europe, and Asia. These...
AI Advances Enable Single-Cell Resolution Cell Senescence Tracking
NYU Langone researchers developed a machine learning method analyzing nuclear morphology to identify and monitor senescent cells at single-cell resolution across diverse tissues and aging stages....
KalVista’s Oral HAE Drug Clears FDA After Delay
KalVista Pharmaceuticals received FDA approval for its oral drug Ekterly (sebetralstat), targeting acute swelling attacks in hereditary angioedema (HAE) patients aged 12 and older. This marks the...
Cogent Biosciences’ Bezuclastinib Advances in Mastocytosis
Cogent Biosciences reported positive Phase II/III data for bezuclastinib, a tyrosine kinase inhibitor targeting systemic mastocytosis (SM), a chronic immune disorder. The registrational trial met...
Apogee Therapeutics Advances Atopic Dermatitis Candidate
Apogee Therapeutics unveiled Phase II results for APG777, an anti-IL-13 antibody for moderate-to-severe atopic dermatitis. The treatment demonstrated a 71% reduction in disease severity versus 34%...
Biotech and Regulatory Shifts Impacting Vaccine Policies
Legal challenges have arisen against HHS Secretary Robert F. Kennedy Jr.’s unilateral removal of COVID-19 vaccine recommendations for pregnant women and healthy children. Medical groups, including...
AI Integration and Innovation in Biotech and Drug Discovery
AI continues to transform biotech, from protein engineering to healthcare delivery. New methods such as AiCE integrate structural and evolutionary constraints for rapid protein design without...
Single-Cell Genomics Expands with Cheaper Sequencing Technologies
Single-cell RNA sequencing (scRNA-seq) matures into a foundational biotechnology, enabling nuanced insights into cellular heterogeneity and disease mechanisms. The International Human Cell Atlas...
Novel Gene Therapy Restores Hearing in Children and Adults
A single-arm clinical trial in China demonstrated that adeno-associated virus (AAV)-mediated OTOF gene therapy improved hearing in both children and young adults with autosomal recessive deafness...
BARDA Funds Basilea’s Broad-Spectrum Antifungal Development
Basilea Pharmaceutica secured $39 million from the U.S. Biomedical Advanced Research and Development Authority (BARDA) as part of a potential $268 million long-term contract to develop novel...
New Insights Reveal Steroid Therapy Undermines Lung Cancer Immunotherapy
A study led by USC researchers found that high-dose corticosteroid use in non-small cell lung cancer (NSCLC) patients undermines the efficacy of immune checkpoint inhibitors (ICIs). The steroids...
Biotech Workforce and FDA Morale Under Political and Administrative Strain
The FDA faces a significant morale crisis amid a recent wave of layoffs and ongoing political pressures, leading to an exodus of experienced staff across drug, device, biologics, and food centers....