Results 31 to 40 of about 4,829,888 (359)

Valuation implications of pharmaceutical companies' R&D regulatory approval notifications [PDF]

open access: yes, 2013
This paper examines shareholder wealth effects surrounding applications to, and approvals by, the United States Food and Drug Administration (FDA) for firms listed on the New York (NYSE) and London (LSE) stock exchanges.
Hamill, P.A., McIlkenny, P., Opong, K.K.
core   +1 more source

Identification of Antiviral Drug Candidates against SARS-CoV-2 from FDA-Approved Drugs

open access: yesAntimicrobial Agents and Chemotherapy, 2020
Drug repositioning is the only feasible option to immediately address the COVID-19 global challenge. We screened a panel of 48 FDA-approved drugs against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which were preselected by an assay of ...
Sangeun Jeon   +7 more
semanticscholar   +1 more source

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2021

open access: yesOTO Open, 2022
Objective To evaluate new medical devices and drugs pertinent to otolaryngology–head and neck surgery that were approved by the Food and Drug Administration (FDA) in 2021. Data Sources Publicly available FDA device and drug approvals from ENT (ear, nose,
Alexander M. Choi MD   +18 more
doaj   +1 more source

The FDA “black box” warning on antidepressant suicide risk in young adults: More harm than benefits? [PDF]

open access: yes, 2019
The decision made in the year 2004 by the U.S. Food and Drug Administration (FDA) to require a boxed warning on antidepressants regarding the risk of suicidality in young adults still represents a matter of controversy.
Anastasia A.   +12 more
core   +1 more source

Large numbers of patients are needed to obtain additional approvals for new cancer drugs: A retrospective cohort study

open access: yesScientific Reports, 2023
Patients endure risk and uncertainty when they participate in clinical trials. We previously estimated that 12,217 patient-participants are required to bring a new cancer drug to market.
Charlotte Ouimet   +5 more
doaj   +1 more source

Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysisResearch in context

open access: yesThe Lancet Regional Health. Americas, 2023
Summary: Background: Most cancer drugs enter the US market first. US Food and Drug Administration (FDA) approvals of new cancer drugs may influence regulatory decisions in other settings.
Adriana M. Ivama-Brummell   +7 more
doaj   +1 more source

Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]

open access: yes, 2014
A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core   +3 more sources

Alchemical analysis of FDA approved drugs

open access: yesDigital Discovery, 2023
Reaction informatics is used to map the chemical space of drugs paired by similarity according to different molecular fingerprints.
Markus Orsi   +3 more
openaire   +3 more sources

Virtual screening and repurposing of FDA approved drugs against COVID-19 main protease

open access: yesLife Science, 2020
Aims In December 2019, the Coronavirus disease-2019 (COVID-19) virus has emerged in Wuhan, China. In this research, the first resolved COVID-19 crystal structure (main protease) was targeted in a virtual screening study by of FDA approved drugs dataset ...
Mahmoud Kandeel, M. Al-Nazawi
semanticscholar   +1 more source

Systems Pharmacology [PDF]

open access: yes, 2008
The slides are from a presentation given by Professor Ravi Iyengar from Mount Sinai School of Medicine at the Drug Forum Meeting #9 that took place in Washington, DC on February 20-21, 2008.
Ravi Iyengar
core   +2 more sources

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