Results 171 to 180 of about 159,613 (271)

Editorial: Global Regulatory Initiatives Deliver Accelerated Approval of the First Bispecific Therapeutic Monoclonal Antibody for Advanced Non-Small Cell Lung Cancer (NSCLC)

, 2021
Dinah V. Parums
openalex   +1 more source

Supraparticles Composed of Graphitic Carbon Nitride Nanoparticles and Silica‐Supported Horseradish Peroxidase as Customizable Hybrid Catalysts for Photo‐Biocatalytic Cascade Reactions in Continuous Flow

Advanced Functional Materials, EarlyView.
Herein presented supraparticles combine the nanoparticulate photocatalyst graphitic carbon nitride with the enzyme horseradish peroxidase, which is immobilized on silica nanoparticles. In an optimized compatibility range, both catalysts operate effectively within the hybrid supraparticles and catalyze a cascade reaction consisting of the photocatalytic
Bettina Herbig, Egzon Cermjani, Doris Hanselmann, Johannes Prieschl, Angelika Schmitt, Michael S. Moritz, Christian Papp, Greta Nölke, Stefano Di Fiore, Christoph Deckers, Thomas H. Rehm, Susanne Wintzheimer   +11 more
wiley   +1 more source

Oncology Accelerated Approval Confirmatory Trials: When a Failed Trial Is Not a Failed Drug. [PDF]

J Clin Oncol
Mehta GU, Pazdur R.
europepmc   +1 more source

Recommendations for the development of rare disease drugs using the accelerated approval pathway and for qualifying biomarkers as primary endpoints [PDF]

, 2015
Emil Kakkis, Mary O’Donovan, Gerald F. Cox, Mark P. Hayes, Federico Goodsaid, P.K. Tandon, Pat Furlong, Susan Boynton, Mladen Bozic, M Orfali, Mark Thornton   +10 more
openalex   +1 more source

A Bespoke Programmable Interpenetrating Elastomer Network Composite Laryngeal Stent for Expedited Paediatric Laryngotracheal Reconstruction

Advanced Functional Materials, EarlyView.
A programmable interpenetrating double‐network architecture, created via 3D‐TIPS printing and resin infusion, synergistically combines thermoplastic and thermosetting elastomers to balance structural rigidity and surface softness—crucial for paediatric laryngeal stents.
Elizabeth F. Maughan, Lei Wu, Dong Zhang, Linxiao Wu, Graca Ferreira Vaz Pinto Mendes, Wanqiao J. Tu, Heping Ma, Toby J. Proctor, Colin R. Butler, Thomas Kjærgaard, Mark W. Lowdell, Martin A. Birchall, Robert E. Hynds, Richard Hewitt, Wenhui Song   +14 more
wiley   +1 more source

Accelerating evidence gathering and approval of precision medicine therapies: the FDA takes aim at rare mutations [PDF]

, 2018
Amalia M. Issa, Adrian Thorogood, Yann Joly, Bartha Maria Knoppers   +3 more
openalex   +1 more source

Curved Nanographene–Graphite Hybrid Anodes with Sequential Li+ Insertion for Fast‐Charging and Long‐Life Li‐Ion Batteries

Advanced Functional Materials, EarlyView.
A hybrid anode composed of Cl‐functionalized curved nanographene and graphite enables ultra‐fast charging and long cycle life through an engineered morphology and sequential Li+ insertion. It delivers 100 mAh g−1 at 5 C with 70% capacity retention after 1000 cycles and maintains stable performance over 2000 cycles in pouch cells, providing a practical ...
Hyunji Cha, Minsung Kang, Seung Hak Oh, Jee Ho Ha, Jeongmi Joo, Dae Hyeon Kwon, Sang Kyu Kwak, Seokhoon Ahn, Seok Ju Kang   +8 more
wiley   +1 more source

Postmarket Safety Actions for Novel Oncology Drugs Granted FDA's Accelerated Approval.

JAMA Netw Open
Mooghali M, Wallach JD, Mitchell AP, Ross JS, Ramachandran R.   +4 more
europepmc   +1 more source

US Food and Drug Administration Accelerated Approval Program for Nononcology Drug Indications Between 1992 and 2018.

JAMA Netw Open, 2022
Omae K, Onishi A, Sahker E, Furukawa TA.
europepmc   +1 more source

Light‐Responsive Enzyme‐Loaded Nanoparticles for Tunable Adhesion and Mechanical Wound Contraction

Advanced Functional Materials, EarlyView.
This study presents a photoactivatable enzyme‐loaded mesoporous nanoparticle system (MPDA_PaTy) that enables light‐triggered tunable tissue adhesion and facilitates mechanical wound contraction. Controlled enzymatic crosslinking at tissue or hydrogel interfaces allows on‐demand adhesion.
Junghyeon Ko, Hyeon‐Jin Kim, Jeong‐Uk Kim, Seh Ri Oh, Tae Hoon Kang, Junghwan Byun, Uk‐Jae Lee, Minglin Ma, Su‐Hwan Kim, Byung‐Gee Kim, Nathaniel S. Hwang   +10 more
wiley   +1 more source