Biotech & Medicine
185 articles RSS
FDA Approves Otsuka's Simtriyo, the First Triple-Reuptake Inhibitor for ADHD in Adults and Children
Otsuka's Simtriyo (centanafadine) becomes the first approved norepinephrine-dopamine-serotonin reuptake inhibitor for ADHD, backed by four Phase 3 trials, with a boxed warning and DEA scheduling still pending.
Fate Therapeutics Wins FDA Clearance for FT839, a Dual-CAR T-Cell Therapy for Autoimmune Disease
FDA cleared the IND for FT839, an off-the-shelf CAR T-cell candidate co-targeting CD19 and CD38 across five autoimmune diseases without chemotherapy conditioning.
Germline-Targeting HIV Vaccine Elicits Broadly Neutralizing Antibodies in 44% of Primates, Nature Study Finds
A Scripps Research and La Jolla Institute for Immunology vaccine guided rhesus macaques to produce broadly neutralizing HIV antibodies, with human trials already underway.
Chinese University Investigates Neuroscientist After Undisclosed Death of Girl, 6, in Brain-Directed Gene-Editing Trial
Shanghai Jiao Tong University is investigating neuroscientist Zilong Qiu after a 6-year-old girl died from a severe immune reaction in an experimental gene-editing trial that went undisclosed.
US Measles Cases Surpass All of 2025's Total With Five Months Still Left in the Year
The CDC had logged 2,318 measles cases by July 23, already above 2025's full-year total of 2,289, as national vaccination rates remain below the outbreak threshold.
AI-Designed Synthetic CRISPR Enzymes Outperform Natural Gene-Editing Tools, Doudna Lab Reports in Science
Jennifer Doudna's team used AI protein design to create synthetic TnpB nucleases that edited human genes more efficiently than the natural enzyme.
Biogen's Tau-Targeting Diranersen Misses Its Primary Endpoint in Phase 2 but Cuts Brain Tau and Slows Alzheimer's Decline
Biogen's diranersen, an antisense drug aimed at tau, missed its Phase 2 dose-response endpoint but slowed cognitive decline and cut brain tau across all doses. Biogen is advancing to Phase 3.
FDA Approves Revtorpyk (Gedatolisib), First Pan-PI3K/mTOR Inhibitor for HR-Positive, HER2-Negative Advanced Breast Cancer
The FDA approved Celcuity's gedatolisib for PIK3CA wild-type HR+/HER2- advanced breast cancer after it more than tripled progression-free survival over fulvestrant alone in the Phase 3 VIKTORIA-1 trial.
Semaglutide Slows Epigenetic Aging in First Randomized Trial, Nature Communications Study of HIV Patients Finds
A UC San Diego-led trial found semaglutide significantly slowed multiple epigenetic aging clocks over 32 weeks in adults with HIV-associated lipohypertrophy, per a Nature Communications study.
Chai Discovery Raises $400 Million Series C at $3.8 Billion Valuation as Pfizer, Lilly and Novartis Deals Pile Up
AI drug-design startup Chai Discovery raised $400 million at a $3.8 billion valuation, nearly tripling its worth in seven months as Pfizer, Eli Lilly and Novartis sign on.
ARPA-H Awards $160 Million to Seven Teams to Build Scalable Gene-Editing Platforms for Rare Pediatric Diseases
ARPA-H's new THRIVE program is funding seven teams to build reusable gene-editing platforms for rare pediatric diseases, aiming to move beyond one-patient-at-a-time therapies like the one made for infant KJ Muldoon.
FDA Approves Subcutaneous Starting Dose for Leqembi Iqlik, Bringing At-Home Initiation to Early Alzheimer's Treatment
The FDA cleared a subcutaneous starting dose for Eisai and Biogen's Leqembi Iqlik, letting early Alzheimer's patients begin anti-amyloid treatment with a 15-second at-home injection instead of IV infusion.