Results 151 to 160 of about 812,951 (357)
Harnessing Nanohybridized Niclosamide for Precision Mpox Therapeutics
Advanced Healthcare Materials, EarlyView.This study investigates the potential of nanohybridized niclosamide as a therapeutic agent for Mpox, focusing on enhanced bioavailability, improved antiviral efficacy, and controlled drug release achieved through nanoengineering. The research emphasizes significant advancements in formulation strategies, mechanistic insights, and therapeutic outcomes ...
N. Sanoj Rejinold +2 more
wiley +1 more source
Harmonizing Safety and Speed: A Human-Algorithm Approach to Enhance the FDA's Medical Device Clearance Policy [PDF]
arXivThe United States Food and Drug Administration's (FDA's) Premarket Notification 510(K) pathway allows manufacturers to gain approval for a medical device by demonstrating its substantial equivalence to another legally marketed device. However, the inherent ambiguity of this regulatory procedure has led to high recall rates for many devices cleared ...
arxiv
Imine Crosslinked, Injectable, and Self‐Healing Fucoidan Hydrogel with Immunomodulatory Properties
Advanced Healthcare Materials, EarlyView.This study develops an injectable fucoidan‐based hydrogel with tunable properties for tissue engineering. By oxidizing fucoidan (OFu) to introduce aldehydes, imine crosslinks are formed with amine‐containing polymers, enabling self‐healing, injectability, and long‐term stability (≥28 days). The OFu‐gelatin hydrogel demonstrated biocompatibility, immune‐
Asma Talib Qureshi +3 more
wiley +1 more source
A Reanalysis of the FDA's Benefit-Risk Assessment of Moderna's mRNA-1273 COVID Vaccine: For 18-25-Year-Old Males, Risks Exceeded Benefits Relative to Hospitalizations [PDF]
arXivThe FDA conducted a benefit-risk assessment for Moderna's COVID vaccine mRNA-1273 prior to its full approval (announced 1/31/2022). The FDA focused its assessment on males of ages 18-64 years because the agency's risk analysis was limited to vaccine-attributable myocarditis/pericarditis (VAM/P) given the excess risk among males.
arxiv
Regulatory Science Needs for Neonates: A Call for Neonatal Community Collaboration and Innovation
Frontiers in Pediatrics, 2014 Susan K McCune, Yeruk Ager Mulugeta
doaj +1 more source
FDA announces reforms of drug review process [PDF]
, 1991 Christopher Anderson
openalex +1 more source
Dendrimer Conjugates with PD‐L1‐Binding Peptides Enhance In Vivo Antitumor Immune Response
Advanced Healthcare Materials, EarlyView.In this paper, a novel nanoparticle scaffold composed of dendrimers conjugated with peptide‐based immune checkpoint inhibitors, enhancing drug delivery efficacy is introduced. By conjugating PD‐L1‐binding peptides to dendrimers, multivalent binding effects are harnessed, resulting in enhanced binding affinity, prolonged half‐life, and improved ...
DaWon Kim +11 more
wiley +1 more source
Advanced Healthcare Materials, EarlyView.The biocompatibility of alginate dialdehyde (ADA) and gelatin (GEL) hydrogels cross‐linked with human transglutaminase (hTG) is demonstrated in vivo with a high degree of stability and angiogenic potential. The additional enzymatic cross‐linker hTG and the increased concentration improve stability and angiogenic potential. The X‐ray microscopy (XRM) is
Stefanie Heltmann‐Meyer +12 more
wiley +1 more source