Biotech & Medicine
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Rockefeller's Redesigned CD40 Antibody Eliminates Metastatic Cancers in Phase 1 Trial, Sparking Nearly 200-Patient Expansion
An Fc-engineered CD40 agonist injected into a single tumor triggered systemic immune responses that eliminated cancer across the body in two patients, with expanded trials now under way at Memorial Sloan Kettering and Duke.
NIH Study Reveals Astrocytes Actively Shape Fear Memory in the Amygdala, Challenging Decades of Neuron-Centric Models
A Nature study finds that star-shaped brain cells called astrocytes encode, maintain, and regulate fear memories alongside neurons, opening new paths for PTSD treatment.
FDA Approves Eli Lilly's Foundayo, a Once-Daily Oral GLP-1 Pill for Obesity With No Food or Water Restrictions
The FDA approved Foundayo (orforglipron), a once-daily oral GLP-1 receptor agonist from Eli Lilly, for adults with obesity or overweight. It is the first new molecular entity approved under the National Priority Voucher program and the fastest NME approval since 2002.
Cultivated Meat Hits a Regulatory Wall in the U.S. as Australia Opens Retail Sales and Eight States Enforce Bans
The Eleventh Circuit upholds Florida's cultivated meat ban as Australia launches consumer retail, splitting the global market between expansion and prohibition.
Nia Therapeutics Wins First FDA Breakthrough Designation for a Brain Implant That Treats Memory Loss After Traumatic Brain Injury
The FDA granted Breakthrough Device Designation to Nia Therapeutics' 60-channel Smart Neurostimulation System, a closed-loop brain implant that uses machine learning to detect impaired memory encoding and deliver targeted stimulation, marking the first such designation for TBI-related memory loss.
FDA Grants Accelerated Approval to First Gene Therapy for Severe Leukocyte Adhesion Deficiency, Capping a Two-Year Regulatory Journey
Rocket Pharmaceuticals' Kresladi becomes the first gene therapy approved for LAD-I, an ultra-rare immune disorder that leaves children vulnerable to fatal infections.
FDA Approves First Once-Weekly Insulin for Type 2 Diabetes, Ending Two Decades of Daily Injections
Novo Nordisk's Awiqli reduces basal insulin injections from 365 to 52 per year, winning FDA approval after a 2024 rejection over manufacturing and safety concerns.
Engineered CD40 Antibody Eliminates Metastatic Cancers in Two Patients After Single-Tumor Injection, Sparking Expanded Trials
A redesigned CD40 agonist antibody injected into a single tumor triggered body-wide immune responses that eliminated all metastases in two patients, with nearly 200 now enrolled in follow-up trials.
Shingles Vaccine Cuts Major Cardiac Events by 46 Percent in Heart Disease Patients, Rivaling the Benefits of Quitting Smoking
A study of nearly 250,000 U.S. adults finds the shingles vaccine dramatically reduces heart attacks, strokes, and deaths in people with existing cardiovascular disease.
First Targeted Therapy for Dermatomyositis Succeeds in Landmark 52-Week Trial, Published in NEJM With FDA Priority Review
Brepocitinib, a first-in-class TYK2/JAK1 inhibitor, hit all primary and secondary endpoints in the largest-ever dermatomyositis trial, offering the first steroid-sparing treatment for a disease that has lacked targeted therapy for decades.
First Lab-Grown Oesophagus Restores Swallowing in Pigs Without Immunosuppression, Paving the Way for Pediatric Trials Within Five Years
UCL and Great Ormond Street Hospital scientists built a functional oesophagus from a donor scaffold and the recipient's own cells, restoring normal eating in eight pigs within six months.
AstraZeneca's Tozorakimab Succeeds in Two Phase 3 COPD Trials Where Rivals Failed, Validating IL-33 as a Drug Target
Tozorakimab becomes the first IL-33-targeting biologic to show statistically significant reductions in COPD exacerbations across two confirmatory Phase 3 trials, after competitors Sanofi and Roche stumbled in the same drug class.