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FDA Commissioner Makary pushes for modernized drug review pathways
FDA Commissioner Martin Makary unveiled a pilot Commissioner’s National Priority Voucher (CNPV) program aiming to accelerate drug reviews for medicines addressing U.S. national priorities such as...
New insights into PTSD brain cell communication deficits
Using advanced single-nucleus RNA sequencing and chromatin accessibility assays, researchers mapped over two million nuclei from human prefrontal cortex samples from PTSD patients, depressed...
Advancements in 3D immunohistochemistry with nanobody conjugates
Researchers at Juntendo University have developed a novel 3D immunohistochemistry technique enhancing rapid and deep tissue imaging, significantly reducing traditional processing times. The method...
Lanthanide–Carbon Triple Bond Discovery Locked in Fullerene Cage
Researchers have synthesized a lanthanide–carbon triple bond encapsulated within an endohedral fullerene cage, specifically a cerium–carbide cluster [Ce≡CSc2] inside a C80 fullerene. This...
FDA Launches Commissioner’s National Priority Voucher to Expedite Drug Reviews
The U.S. Food and Drug Administration (FDA) announced a pilot program offering Commissioner’s National Priority Vouchers (CNPVs) that enable certain drugs addressing national health priorities to...
Gilead Secures FDA Approval for Twice-Yearly HIV Prevention Injection
Gilead Sciences achieved a landmark FDA approval for lenacapavir (brand name Yeztugo), the first HIV pre-exposure prophylaxis (PrEP) drug administered twice yearly by injection. This long-acting...
In Vivo Generation of CAR T Cells Using Targeted Lipid Nanoparticles
A novel immunotherapy approach enables direct in vivo creation of CAR T cells using targeted lipid nanoparticles (tLNPs), bypassing complex ex vivo cell engineering processes. This strategy...
Parkinson’s Disease Sleep Dysfunction Ameliorated by Butyrate Through BDNF Pathway
A study demonstrates that butyrate, a short-chain fatty acid produced by gut microbiota, restores abnormal sleep architecture in a Parkinson’s disease mouse model by activating the brain-derived...
Patient-Centric Focus Drives Biotech Innovation at BIO 2025 Convention
At the 2025 BIO International Convention, industry leaders reiterated the centrality of patients to biotechnology innovation. Panels highlighted the vital role of patient advocacy, including...
New Scheduling Model Enhances Neonatal Intensive Care Efficiency and Staff Wellbeing
A cutting-edge hours-based scheduling system tailored for neonatal intensive care units (NICUs) has been developed to improve patient outcomes and provider wellbeing. Departing from traditional...
Critical Gaps in Environmental Chemical Monitoring Threaten Aquatic Ecosystem Safety
Recent investigations reveal substantial shortcomings in chemical monitoring programs, with under 1% of the estimated 300,000 chemicals of environmental concern regularly assessed in U.S. surface...
Zealand Pharma’s Dual GLP-1/GLP-2 Agonist Demonstrates Robust Weight Loss in Phase 1b
Zealand Pharma reported updated phase 1b results for its dapiglutide, a dual glucagon-like peptide-1 and peptide-2 receptor agonist, showing an average body weight reduction of 11.6% after 28...
Scholar Rock’s Myostatin Blocker Preserves Lean Mass with Obesity Treatment
In a Phase 2 study, Scholar Rock’s apitegromab, an anti-myostatin antibody, was shown to preserve lean muscle mass in patients undergoing weight loss therapy with Eli Lilly’s Zepbound...
FDA Overhauls Drug Review Process Amid Leadership Changes
The U.S. Food and Drug Administration (FDA) is undergoing significant shifts in leadership and procedural reforms aimed at accelerating drug approval timelines. Key cell and gene therapy leaders...
Gilead’s Twice-Yearly HIV Prevention Shot Gains FDA Approval
The FDA approved Gilead Sciences’ lenacapavir (commercially Yeztugo), a long-acting injectable pre-exposure prophylaxis (PrEP) treatment against HIV that requires just two injections annually....
Lilly’s $1.3B Bet on Gene Therapies for Cardiovascular Disease
Eli Lilly advanced its gene therapy pipeline with a $1.3 billion acquisition of CRISPR startup Verve Therapeutics, adding VERVE-102, an in vivo CRISPR base editor targeting PCSK9 for...
Financial Strain Widens Among Biotech Firms: EY Reports
The latest EY Biotech Beyond Borders report reveals that nearly 40% of biotech companies face cash runways shorter than 12 months — the highest level in over six years. This alarming trend...
Artificial Cells Production Breakthrough Using Microfluidics
Researchers led by Professor Hiroaki Suzuki at Chuo University have pioneered a microfluidic-based technology for mass-producing uniform artificial cells containing DNA condensates simulating...
Zealand Pharma’s GLP-1/GLP-2 Dual Agonist Shows Promising Weight Loss Results
Zealand Pharma reported updated phase 1b trial data for its dual GLP-1/GLP-2 receptor agonist dapiglutide, with patients on higher dosing regimens experiencing mean body weight reductions of 11.6%...
Qiagen Launches Digital PCR Partnering Program for Oncology Assays
Qiagen has initiated a third-party partnering program to expand its clinical digital PCR platform's test menu, signing South Korea-based Gencurix Oncology as the inaugural partner. The...