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Cogent’s Mastocytosis Drug Clears Phase II with Positive Data
Cogent Biosciences’ bezuclastinib demonstrated statistically significant improvements in indolent systemic mastocytosis during a registrational Phase II study, producing meaningful symptomatic...
ProKidney’s Cell Therapy Shows Mixed Phase II CKD Results with Stock Spike
ProKidney’s autologous cell therapy rilparencel reported a 78% slowing of kidney function decline in one patient cohort of a Phase II chronic kidney disease trial, while a second cohort showed a...
Novartis Secures Newborn Approval for Malaria Therapy Coartem Baby
Novartis gained Swiss regulatory clearance for Coartem Baby, the first malaria treatment formulated specifically for newborns and young infants. The new dosing addresses an unmet need for safe,...
Artificial Intelligence Advances Protein Engineering and Synthetic Biology
Researchers have developed new AI-driven techniques to rapidly engineer proteins by integrating structural and evolutionary constraints without custom training for specific proteins. Additionally,...
FDA Faces Staff Exodus Amid Morale Crisis Impacting Drug Reviews
The FDA is experiencing a significant morale and staffing crisis following major personnel departures in April and ongoing talent losses. This exodus threatens the agency’s capacity to maintain...
CRISPR and Gene Therapy Partnerships Push Genomic Medicine Forward
Collaborations and clinical advances mark progress in gene editing and therapeutic development. Abu Dhabi’s DoH joined forces with UCSF and Innovative Genomics Institute to establish genome...
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...