Biotech & Medicine
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FDA Approves Baxfendy, the First Aldosterone Synthase Inhibitor for Uncontrolled Hypertension
AstraZeneca's baxdrostat (Baxfendy) became the first aldosterone synthase inhibitor approved in the US on May 18, 2026, giving the estimated 23 million Americans whose blood pressure remains uncontrolled on two or more drugs a new mechanistic option.
Sleep Brain Waves Predict Dementia Risk Decades Before Symptoms, Large Study Finds
A machine-learning analysis of sleep EEG data from 7,105 adults found that each 10-year gap between brain age and chronological age raises dementia risk by 39%.
Fractyl Health Wins European Clearance for First GLP-1 Gene Therapy Clinical Trial, Aiming to Replace Daily Injections With a One-Time Pancreas Edit
Fractyl Health received authorization in the Netherlands to run the world's first clinical trial of an AAV-based GLP-1 gene therapy for type 2 diabetes, targeting patients who cannot sustain daily injections.
Cytisinicline Heads Toward FDA Decision as Long-Term Safety Data Backs First New Smoking Cessation Drug in Two Decades
Fresh 52-week safety data presented at ATS 2026 reinforce cytisinicline's profile ahead of a June 20 FDA decision that could bring the first new smoking cessation drug to US patients since 2006.
Nine Weeks of Immunotherapy Before Surgery Leaves Every Bowel Cancer Patient Relapse-Free After 33 Months in NEOPRISM-CRC Trial
A UK trial of preoperative pembrolizumab for MMR-deficient colorectal cancer shows zero relapses across all 32 patients after nearly three years of follow-up.
Encoded's ETX101 Cuts Dravet Seizures 76% at Dose Level 3 and Tracks Toward Neurotypical Development in Children Treated Before Age 2
An AAV9 gene-regulation therapy delivered durable, dose-dependent seizure control and early signs of neurodevelopmental rescue through 52 weeks, just as the pivotal study begins dosing.
FDA Grants Sonrotoclax Accelerated Approval as First BCL-2 Inhibitor for Relapsed/Refractory Mantle Cell Lymphoma
BeOne Medicines' Beqalzi clears the FDA on a 52% overall response rate in 103 post-BTK patients, becoming the first BCL-2 inhibitor specifically approved for MCL and setting up a head-to-head with AbbVie and Roche's off-label Venclexta.
FDA Approves Enhertu for Two HER2-Positive Early Breast Cancer Indications, Moving the AstraZeneca-Daiichi ADC Into Curative-Intent Treatment
AstraZeneca and Daiichi Sankyo's trastuzumab deruxtecan won simultaneous neoadjuvant and adjuvant approvals on May 15, backed by 927-patient DESTINY-Breast11 and 1,635-patient DESTINY-Breast05 Phase III trials.
Two teams publish DNA-guided CRISPR-Cas12 systems in Nature Biotechnology, inverting the RNA-guide paradigm for RNA diagnostics and antivirals
Researchers at the University of Florida and the Hong Kong University of Science and Technology each report a DNA-guided CRISPR-Cas12 platform that targets RNA, reducing off-target effects and enabling attomolar-level pathogen detection.
United Therapeutics Wins FDA Clearance for EXPRESS, the First Pig-Heart Xenotransplant Trial Designed to Support a BLA
The FDA cleared an IND for UHeart, a 10-gene-edited pig heart, opening a single-center phase 1/2/3 trial that will enroll up to two patients with end-stage heart failure before any expansion.
NEJM Publishes Phase 1/2 Data for Daraxonrasib as FDA Authorizes Expanded Access for Metastatic Pancreatic Cancer
NEJM publishes Phase 1/2 data for oral RAS(ON) inhibitor daraxonrasib (~30% ORR, 90% disease control in pretreated patients); FDA issues 'safe to proceed' for EAP on May 1, now available for eligible metastatic PDAC patients.
RNA-Triggered CRISPR System Selectively Kills Cancer and Viral Cells by Shredding Their DNA, Researchers Report in Nature
A University of Utah-led international team reports a new CRISPR nuclease, Cas12a2, that uses RNA guides to trigger widespread DNA shredding and cell death specifically in diseased cells such as KRAS-mutant cancers and HPV-infected cells, while leaving healthy cells unharmed.