Results 81 to 90 of about 159,613 (271)

Regulatory alignment in FDA expedited pathways for infectious diseases: a decadal review with predictive modeling insights

Scientific Reports
Despite infectious diseases being a significant threat to global health, there are continuing concerns that regulatory authorities do not prioritize therapeutic strategies for infectious diseases with the same urgency as those for oncological or orphan ...
Nguyen Thanh Tam, Ahmed M. Sayed, Mohammad Najm Dadam, Randa Elsheikh, Jeza Muhammad Abdul Aziz, Abdelrahman Gamil Gad, Thi Thu Hoai Nguyen, Phillip Tran, Zhilin Zhang, Norio Ohmagari, Nguyen Tien Huy   +10 more
doaj   +1 more source

Keynote-158 study, FDA granted accelerated approval of pembrolizumab for the treatment of patients with advanced PD-L1-positive cervical cancer [PDF]

, 2020
Édith Borcoman, Christophe Le Tourneau
openalex   +1 more source

TMC4 localizes to multiple taste cell types in the mouse taste papillae

FEBS Open Bio, EarlyView.
Transmembrane channel‐like 4 (TMC4), a voltage‐dependent chloride channel, plays a critical role in amiloride‐insensitive salty taste transduction. TMC4 is broadly expressed in all mature taste cell types, suggesting a possible involvement of multiple cell types in this pathway.
Momo Murata, Yoshikazu Saito, Yoichi Kasahara, Wataru Fujii, Takumi Misaka, Tomiko Asakura, Masataka Narukawa   +6 more
wiley   +1 more source

Single-arm clinical trials that supported FDA accelerated approvals have modest effect sizes and were at high risk of bias [PDF]

, 2022
Tatiane Bomfim Ribeiro, Luis Enrique Colunga‐Lozano, Ana Paula Vieira Araujo, Charles L. Bennett, Iztok Hozo, Benjamin Djulbegović   +5 more
openalex   +1 more source

SIRT4 positively regulates autophagy via ULK1, but independently of HDAC6 and OPA1

FEBS Open Bio, EarlyView.
Cells expressing SIRT4 (H161Y), a catalytically inactive mutant of the sirtuin SIRT4, fail to upregulate LC3B‐II and exhibit a reduced autophagic flux under stress conditions. Interestingly, SIRT4(H161Y) promotes phosphorylation of ULK1 at S638 and S758 that are associated with inhibition of autophagy initiation.
Isabell Lehmkuhl, Khawar Amin, Lydia Gabriel, Nils Hampel, Afshin Iram, Julia Hesse, Constanze Wiek, Jasmin Thuy Vy Nguyen, Helmut Hanenberg, Jürgen Scheller, M. Reza Ahmadian, Björn Stork, Doreen M. Floss, Roland P. Piekorz   +13 more
wiley   +1 more source

Accelerated approval requirements for lurbinectedin

The Lancet Oncology, 2022
Benjamin, David J, Prasad, Vinay
openaire   +4 more sources

Metformin promotes mitochondrial integrity through AMPK‐signaling in Leber's hereditary optic neuropathy

FEBS Open Bio, EarlyView.
Metformin mediates mitochondrial quality control in Leber's hereditary optic neuropathy (LHON) fibroblasts carrying mtDNA mutations. At therapeutic levels, metformin activates AMPK signaling to restore mitochondrial dynamics by promoting fusion and restraining fission, while preserving mitochondrial mass, enhancing autophagy/mitophagy and biogenesis ...
Chatnapa Panusatid, Rapasviranda Soiyangsuk, Maneeluck Tanadjindarat, Chayanon Peerapittayamongkol   +3 more
wiley   +1 more source

Regulatory approval for autologous human cells and tissue products in the United States, the European Union, and Japan

Regenerative Therapy, 2015
Human cells and tissue products belong to a relatively new class of medical products. Therefore, limited information is available on the classification and premarket evaluation of human cells and tissue products in the United States (US), the European ...
Kazuo Yano, Natsumi Watanabe, Kenichiro Tsuyuki, Taisuke Ikawa, Hiroshi Kasanuki, Masayuki Yamato   +5 more
doaj   +1 more source

Indinavir marketed under accelerated-approval program [PDF]

, 1996

openalex   +1 more source

KLK7 overexpression promotes an aggressive phenotype and facilitates peritoneal dissemination in colorectal cancer cells

FEBS Open Bio, EarlyView.
KLK7, a tissue kallikrein‐related peptidase, is elevated in advanced colorectal cancer and associated with shorter survival. High KLK7 levels in ascites correlate with peritoneal metastasis. In mice, KLK7 overexpression increases metastasis. In vitro, KLK7 enhances cancer cell proliferation, migration, adhesion, and spheroid formation, driving ...
Yosr Z. Haffani, Tobias Dreyer, Meriem Naim, Rea Lo Dico, Natalia A. Ignatenko, Viktor Magdolen, Dalila Darmoul   +6 more
wiley   +1 more source