Results 91 to 100 of about 757,641 (252)
Frontiers in PharmacologyPurposeDescribe and compare the clinical evidence, post-marketing requirements, and regulatory outcomes of all anticancer drugs that have obtained conditional or accelerated approval based on single-arm trial data in China and the United States ...
Yang Du, Shuo Zhang, Li Yang
doaj +1 more source
Assessing the Impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA Approval Process [PDF]
Congress enacted and renewed the Prescription Drug User Fee Acts (PDUFA) in 1992, and renewed it in 1997 and 2002, mandating FDA performance goals in reviewing and acting on drug applications within specified time periods.
Adrian H. B. Gottschalk +3 more
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Therapeutic Apheresis and Dialysis, EarlyView.ABSTRACT Background Neuromyelitis optica spectrum disorder (NMOSD) is a relapsing autoimmune disease of the central nervous system. High‐dose intravenous methylprednisolone (IVMP) is the standard first‐line therapy for acute attacks, although some patients remain refractory.
Wataru Horiguchi +5 more
wiley +1 more source
FEBS Letters, EarlyView.Enteropathogenic E. coli (EPEC) infects the human intestinal epithelium, resulting in severe illness and diarrhoea. In this study, we compared the infection of cancer‐derived cell lines with human organoid‐derived models of the small intestine. We observed a delayed in attachment, inflammation and cell death on primary cells, indicating that host ...
Mastura Neyazi +5 more
wiley +1 more source
FDA New Drug Approval Times, Prescription Drug User Fees, and R & D Spending [PDF]
FDA-approval times have declined significantly since the enactment of the Prescription Drug User Fee Act (PDUFA) in 1992. As a result, present value expected returns to pharmaceutical R&D have likely increased.
Golec, Joseph H. +3 more
core +1 more source
FDA Approval of Drugs and Devices: Preemption of State Laws for “Parallel” Tort Claims [PDF]
, 2015 The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns whether the Food and Drug Administration’s (“FDA”) approval of a generic drug insulates the drug manufacturer from liability under state tort laws from ...
Boumil, Marcia
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Organoids in pediatric cancer research
FEBS Letters, EarlyView.Organoid technology has revolutionized cancer research, yet its application in pediatric oncology remains limited. Recent advances have enabled the development of pediatric tumor organoids, offering new insights into disease biology, treatment response, and interactions with the tumor microenvironment.
Carla Ríos Arceo, Jarno Drost
wiley +1 more source
FDA Drug Approval: A Black and White Issue? [PDF]
, 2012 The FDA should judiciously limit the FDA approval of race-specific drugs to situations in which the utilization of racial categories is based on statistically significant scientific data and necessity and, in such cases, the meaning of race utilized ...
Yonker, Stephanie A.
core
Maraviroc: integration of a new antiretroviral drug class into clinical practice [PDF]
, 2008 Maraviroc (Pfizer's UK-427857, Selzentry or Celsentri outside the US) is the first agent in the new class of oral HIV-1 entry inhibitors to acquire FDA and EMEA approval.
Vandekerckhove, Linos +2 more
core +2 more sources
Reciprocal control of viral infection and phosphoinositide dynamics
FEBS Letters, EarlyView.Phosphoinositides, although scarce, regulate key cellular processes, including membrane dynamics and signaling. Viruses exploit these lipids to support their entry, replication, assembly, and egress. The central role of phosphoinositides in infection highlights phosphoinositide metabolism as a promising antiviral target.
Marie Déborah Bancilhon, Bruno Mesmin
wiley +1 more source