Biotech & Medicine
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Brain-Computer Interfaces Enter the Commercial Era as China Grants First Approval and BrainGate Achieves Near-Able-Bodied Typing Speeds
China's NMPA approves the world's first commercial brain implant while a BrainGate study demonstrates 110-character-per-minute typing, marking a pivotal week for neural interface technology.
Federal Judge Blocks Kennedy's Overhaul of U.S. Childhood Vaccine Schedule, Invalidates Reconstituted Advisory Panel
A federal court has halted sweeping changes to the national childhood immunization schedule and frozen Kennedy's ACIP appointments, finding the reconstituted panel likely violated federal law.
Mass General Team's INSTALL Platform Solves Gene Therapy's Immune Toxicity Problem, Enabling Safe Non-Viral DNA Insertion in Living Mice
A Nature paper describes INSTALL, a gene editing platform using circular single-stranded DNA to insert therapeutic genes without triggering fatal immune responses, keeping mice healthy at doses where conventional DNA proved lethal.
FDA Lifts Clinical Hold on Intellia's CRISPR Gene-Editing Trial for Heart Disease After Patient Death and Safety Overhaul
The FDA has cleared Intellia Therapeutics to resume its MAGNITUDE Phase 3 trial of nexiguran ziclumeran for ATTR cardiomyopathy, five months after a patient death and subsequent clinical hold prompted a safety overhaul.
Sana Biotechnology Reports 14-Month Survival of Transplanted Islet Cells Without Immunosuppression in a Type 1 Diabetes Patient
Gene-edited pancreatic islet cells transplanted into a patient with type 1 diabetes continue producing insulin 14 months later with no immunosuppressive drugs, advancing the case for a functional cure.
FDA Issues Warning Letter to Novo Nordisk Over Unreported Semaglutide Deaths and Systematic Pharmacovigilance Failures
The FDA cited Novo Nordisk for serious violations of adverse event reporting requirements after a 2025 inspection found the company failed to report three patient deaths linked to semaglutide, including one suicide, and lacked adequate procedures for post-marketing drug safety surveillance.
FDA Pushes Back Orforglipron Decision to April as National Priority Voucher Program Hits Early Turbulence
The FDA has delayed its decision on Eli Lilly's oral obesity pill orforglipron from March 28 to April 10, alongside delays for three other drugs in the new expedited review program.
In Vivo CAR-T Therapy Delivers First Human Proof-of-Concept for Autoimmune Reset, Bypassing Lab Manufacturing
MagicRNA's mRNA lipid nanoparticle therapy reprogrammed patients' own T cells inside the body, wiping out disease-driving B cells in refractory lupus patients without conventional cell manufacturing.
Japan Grants Conditional Approval to the World's First iPS Cell Therapies for Parkinson's Disease and Heart Failure
Japan's health ministry has conditionally approved two iPS cell-derived drugs, marking the first time regenerative medicines built from induced pluripotent stem cells will reach patients commercially.
First Fentanyl Vaccine Enters Human Trials in the Netherlands, Aiming to Block Overdoses Before They Start
ARMR Sciences begins Phase 1 trials of a vaccine that trains the immune system to intercept fentanyl before it reaches the brain, a preventive approach with no precedent in addiction medicine.
Roche's Amylin-Based Weight Loss Drug Delivers 10.7% Reduction in Phase 2 but Falls Short of Eli Lilly's Rival, Sending Zealand Pharma Shares Down 32%
Petrelintide met its primary endpoint with placebo-like tolerability, but a dose ceiling and a seven-point efficacy gap to Lilly's eloralintide raise questions about its standalone future.
FDA Reverses Course on UniQure's Huntington's Gene Therapy, Demanding Sham Surgery Trial in Setback That Could Add Years to Approval Timeline
The FDA rejected uniQure's Phase I/II data for AMT-130 and now demands a sham surgery-controlled Phase 3 trial, reversing its own prior guidance and sending shares down 40 percent.