Results 61 to 70 of about 333,056 (304)

Review and approval of drugs against COVID-19 in Japan

, 2023
Three years have passed since The World Health Organization declared coronavirus disease (COVID-19) as a pandemic on 11 March 2020. In Japan, we have received benefits from new vaccines and drugs against COVID-19.
久野, 篤史
core   +1 more source

Generating comparative evidence on new drugs and devices before approval. [PDF]

, 2020
Fewer than half of new drugs have data on their comparative benefits and harms against existing treatment options at the time of regulatory approval in Europe and the USA.
Salanti, Georgia, Salcher-Konrad, Maximilian, Jackson, Emily, Wieseler, Beate, Rochaix, Lise, Redberg, Rita, Garner, Sarah, Kesselheim, Aaron S., Redberg, Rita F, Naci, Huseyin, Cipriani, Andrea, Kesselheim, Aaron, Stroup, Scott, Dr.rer.nat, Beate Wiesler, Kesselheim, Aaron S, Stroup, T Scott   +15 more
core   +1 more source

Spontaneous closure of patent ductus arteriosus in preterm babies after failed attempts at transcatheter device closure

Annals of Pediatric Cardiology, 2022
Transcatheter closure of patent ductus arteriosus (PDA) for preterm infants is increasingly performed after the Food and Drug Administration approval of the Amplatzer Piccolo Occluder device (Abbott Inc., Abbott Park, IL, USA) in the United States.
Ahmed Deniwar, Matthew Brown, Duraisamy Balaguru   +2 more
doaj   +1 more source

EDNRB‐dependent endothelin signaling reduces proliferation and promotes proneural‐to‐mesenchymal transition in gliomas

Molecular Oncology, EarlyView.
Glioma cells mainly express the endothelin receptor EDNRB, while EDNRA is restricted to a perivascular tumor subpopulation. Endothelin signaling reduces glioma cell proliferation while promoting migration and a proneural‐to‐mesenchymal transition associated with poor prognosis. This pathway activates Ca2+, K+, ERK, and STAT3 signalings and is regulated
Donovan Pineau, Leonor Garcia, Hugo Arnold, Antonija Hanžek, Maialen Arrieta, Laurent R Gauthier, Christine Granotier‐Beckers, François D Boussin, Amaury Herbet, Marie Hautière, Valentin Asei‐Ceschino, Clémentin Jacques, Laura Brard, Thomas Harnois, Valérie Coronas, Bruno Constantin, Aurélien Chatelier, Jean Chemin, Serge Urbach, Martial Seveno, Szimonetta Hideg, Chantal Ripoll, Kasandra Aguilar‐Cázarez, Min Zheng, Guo‐Hao Huang, Sheng‐Qing Lv, Lei Zhang, Philippe Rondard, Laurent Prezeau, Jean‐Philippe Pin, Hugues Duffau, Luc Bauchet, Valérie Rigau, Franck Denat, Charles Truillet, Didier Boquet, Jean‐Philippe Hugnot   +36 more
wiley   +1 more source

Stryker Cutting Guide FDA Approval

, 2023
Medical devices require sufficient testing and documentation to receive US Food and Drug Administration (FDA) approval that they are safe and effective for patients to use.
Wernoch, Lacey
core  

CCDC80 suppresses high‐grade serous ovarian cancer migration via negative regulation of B7‐H3

Molecular Oncology, EarlyView.
PAX8 is a lineage‐specific master regulator of transcription in high‐grade serous ovarian cancer (HGSC) progression. We show for the first time that PAX8 facilitates proliferation and metastasis by repressing the cell autonomous tumor suppressor CCDC80 and inducing B7‐H3 expression.
Aya Saleh, Nitzan Medina‐Itzhaki, Milena Chekov, Eden Gal‐Swisa, Roba Gabesh‐Wahabi, Inbar Savyon, Inna Naroditsky, Hilary A. Kenny, Basem Fares, Lina Korsensky, Einav Girsh, Liron Berger, Ruth Perets   +12 more
wiley   +1 more source

Bridging the Gap in FDA Approval for Pediatric Neuromodulation Devices

Children
While neuromodulation devices for managing neurological conditions have significantly advanced, there remains a substantial gap in FDA-approved devices specifically designed for pediatric patients.
Ammar Shaikhouni, Cameron Brandon, Cory Criss   +2 more
doaj   +1 more source

CD47 promotes mitogen‐activated protein kinase and epithelial‐to‐mesenchymal transition molecular programs to drive prometastatic phenotypes in non‐small cell lung cancer

Molecular Oncology, EarlyView.
Beyond its role in immune evasion, this study identified that CD47 drives tumor‐intrinsic signaling in non‐small cell lung cancer (NSCLC). Transcriptomic profiling and functional studies revealed that CD47 regulates cell adhesion, migration, and metastasis through an ERK–EMT signaling axis.
Asa P.Y. Lau, Lilian G. Zhai, Ryunosuke Hoshi, Zackary Rousseau, Abraam Zakhary, Yin Fang Wu, Rola M. Saleeb, Heyu Ni, Kelsie L. Thu   +8 more
wiley   +1 more source

Accelerated Approval – Taking the FDA’s Concerns Seriously

, 2022
As the U.S. Congress debates a must-pass bill reauthorizing Food and Drug Administration (FDA) user fees for drug and device companies, the future of the FDA’s accelerated-approval program has become a focus of policy discussion.
Donohue, Julie M., Sachs, Rachel, Dusetzina, Stacie B.   +2 more
core   +1 more source

Who Still Gets Ligated? Reasons for Persistence of Surgical Ligation of the Patent Ductus Arteriosus Following Availability of Transcatheter Device Occlusion for Premature Neonates

Journal of Cardiovascular Development and Disease
(1) Background: To identify reasons for the persistence of surgical ligation of the patent ductus arteriosus (PDA) in premature infants after the 2019 Food and Drug Administration (FDA) approval of transcatheter device closure; (2) Methods: We performed ...
Julia K. Hoffmann, Zahra Khazal, Wievineke Apers, Puneet Sharma, Constance G. Weismann, Kira Kaganov, Craig R. Wheeler, Michael Farias, Diego Porras, Philip Levy, Sarah U. Morton   +10 more
doaj   +1 more source