Use of Clinical Outcome Assessments in New Drug Approvals by the US Food and Drug Administration Divisions of Neurology I and II
Sign Up to like & getrecommendations! Published in 2022 at "JAMA Network Open"
DOI: 10.1001/jamanetworkopen.2022.30530
Abstract: This cross-sectional study examines drug approvals by the US Food and Drug Administration (FDA) Divisions of Neurology I and II to understand the role of clinical outcome assessments in regulatory decisions, including whether and how… read more here.
Keywords: neurology; food drug; approvals food; drug administration ... See more keywords
New drug approvals for 2022: Synthesis and clinical applications.
Sign Up to like & getrecommendations! Published in 2023 at "Medicinal research reviews"
DOI: 10.1002/med.21976
Abstract: The U.S. Food and Drug Administration has approved a total of 37 new drugs in 2022, which are composed of 20 chemical entities and 17 biologics. In particular, 20 chemical entities, including 17 small molecule… read more here.
Keywords: new drug; synthesis; mechanism action; chemical ... See more keywords
The race for drug approvals: hasten slowly?
Sign Up to like & getrecommendations! Published in 2018 at "European Journal of Clinical Pharmacology"
DOI: 10.1007/s00228-018-2490-9
Abstract: Zeukeng et al. compared characteristics of approvals by the Food and Drug Administration (FDA), the European Medicine Agency (EMA), and Swissmedic (SMC): (a) indications approved for the same drugs were similar in content for only… read more here.
Keywords: race drug; drug; hasten slowly; race ... See more keywords
The impact of external innovation on new drug approvals: A retrospective analysis
Sign Up to like & getrecommendations! Published in 2019 at "International Journal of Pharmaceutics"
DOI: 10.1016/j.ijpharm.2018.12.093
Abstract: Graphical abstract Figure. No caption available. HighlightsThe FDA approved a total of 251 NMEs and 67 biologics during 2006–2016.Pre‐approval publications can provide insight on the innovation ecosystem.Text mining identifies major research contributions of each organization.Sponsors… read more here.
Keywords: research; external innovation; innovation; drug ... See more keywords
2017 FDA drug approvals
Sign Up to like & getrecommendations! Published in 2018 at "Nature Reviews Drug Discovery"
DOI: 10.1038/nrd.2018.18
Abstract: This corrects the article DOI: 10.1038/nrd.2018.4 read more here.
Keywords: drug; 2017 fda; drug approvals; fda drug ... See more keywords
Regulatory watch: FDA new drug approvals in Q3 2018
Sign Up to like & getrecommendations! Published in 2018 at "Nature Reviews Drug Discovery"
DOI: 10.1038/nrd.2018.194
Abstract: With one full quarter still to go before the end of the year, 41 novel drugs have already been approved by the FDA, putting 2018 on track to surpass 1996’s record 53 new drug approvals.… read more here.
Keywords: regulatory watch; new drug; drug; first class ... See more keywords
Ophthalmic Drug Discovery in the United States over the past Two Decades
Sign Up to like & getrecommendations! Published in 2020 at "Ophthalmic Epidemiology"
DOI: 10.1080/09286586.2020.1786591
Abstract: ABSTRACT Purpose Pharmaceutical development has slowed since the turn of the century and there has been recent legislation passed that aims to accelerate drug approval. Ophthalmic drug discovery has unique challenges that may benefit from… read more here.
Keywords: drug; drug discovery; drug approvals; ophthalmic drug ... See more keywords
Changes in mortality associated with cancer drug approvals in the United States from 2000 to 2016
Sign Up to like & getrecommendations! Published in 2020 at "Journal of Medical Economics"
DOI: 10.1080/13696998.2020.1834403
Abstract: Abstract Aims To estimate the extent to which the approvals of new pharmacological therapies were associated with cancer mortality in the USA between 2000 and 2016. Materials and methods The analysis quantified cancer drug approvals… read more here.
Keywords: mortality; cancer; 2000 2016; drug approvals ... See more keywords
New Endpoints, Programs Used for Drug Approvals.
Sign Up to like & getrecommendations! Published in 2019 at "Cancer discovery"
DOI: 10.1158/2159-8290.cd-nb2019-010
Abstract: The FDA greenlighted 17 novel cancer agents in 2018, including one with a novel endpoint in a clinical trial and one through an expanded access program. The agency also approved five biosimilars to treat cancer… read more here.
Keywords: drug approvals; cancer; new endpoints; programs used ... See more keywords
By the Numbers: Percent Share of Novel FDA Drug Approvals in Four Major Therapeutic Categories, 1980-2018.
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DOI: 10.1158/2159-8290.cd-nb2019-119
Abstract: Between 1980 and 2018, novel cancer drug approvals as a percentage share of all novel FDA drug approvals increased from 4.5% to 26.7%. read more here.
Keywords: share novel; drug; drug approvals; 1980 2018 ... See more keywords
Trends and Perspectives of Biological Drug Approvals by the FDA: A Review from 2015 to 2021
Sign Up to like & getrecommendations! Published in 2022 at "Biomedicines"
DOI: 10.3390/biomedicines10092325
Abstract: Despite belonging to a relatively new class of pharmaceuticals, biological drugs have been used since the 1980s, when they brought about a breakthrough in the treatment of chronic diseases, especially cancer. They conquered a large… read more here.
Keywords: biological drug; 2015 2021; perspectives biological; trends perspectives ... See more keywords