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1 FDA drug review times declined from more than 3 years in
2 FDA guidance recommends conducting in vitro skin permeat
3 FDA or EUCAST breakpoints should be applied to interpret
4 FDA-approved assays for fungal diagnosis are generally f
5 FDA-approved enzalutamide is commonly prescribed for CRP
6 FDA-approved RAF inhibitors poorly inhibit BRAF dimers,
9 e like cell lines treated with a panel of 26 FDA-approved KIs and classify their effects on subcellul
13 ity at 65% and 66%, compared to 74% and 72% (FDA) and 87% and 89% (CLSI) by HardyDisks and MASTDISCS,
14 publicly available databases, we curated 883 FDA approved or investigational stage small molecule can
18 ned with the US Food and Drug Administation (FDA)-approved drugs Orkambi (lumacaftor/ivacaftor) and T
19 following U.S. Food and Drug Administration (FDA) and International Standards Organization (ISO) stan
20 United States Food and Drug Administration (FDA) and other regulatory agencies about developing crit
21 7-28, 2018 the Food and Drug Administration (FDA) and the Critical Path Institute's Transplant Therap
22 ue-agnostic US Food and Drug Administration (FDA) approval for adult and pediatric patients with Trk-
23 hough the U.S. Food and Drug Administration (FDA) approved for transport and culture of enteric bacte
24 ts that are US Food and Drug Administration (FDA) approved in the upfront and the recurrent setting.
25 ed by the U.S. Food and Drug Administration (FDA) as "breakthrough therapies" for posttraumatic stres
26 oved by the US Food and Drug Administration (FDA) between 2009 and 2018 to estimate the research and
27 t and the U.S. Food and Drug Administration (FDA) Bioanalytical Method Validation Guidance for Indust
28 In 2016, the Food and Drug Administration (FDA) changed labeling regarding metformin contraindicati
29 successful US Food and Drug Administration (FDA) de novo authorization of an example, the first auto
30 ch access, the Food and Drug Administration (FDA) developed a model drug facts label for such sales t
31 available U.S. Food and Drug Administration (FDA) drug reviews, all reported CVD events across latter
32 Although U.S. Food and Drug Administration (FDA) drugs are approved for the treatment of influenza i
36 ed by the U.S. Food and Drug Administration (FDA) for in vitro diagnostic use, assays for the detecti
39 oved by the US Food and Drug Administration (FDA) for r/r ALL (CD19CAR T-cell approval is restricted
43 xamined by the Food and Drug Administration (FDA) in this investigation have been found to contain VE
44 nge for the US Food and Drug Administration (FDA) is to achieve an appropriate balance between rigoro
47 waters of the Food and Drug Administration (FDA) new-drug application (NDA) process that ultimately
48 Neither the Food and Drug Administration (FDA) nor the Clinical and Laboratory Standards Institute
50 that the U.S. Food and Drug Administration (FDA) plays in its regulation of neuroimplantable technol
53 l (ODP) of the Food and Drug Administration (FDA) to determine whether a relationship exists between
54 tted to the US Food and Drug Administration (FDA) were analyzed to map the safety profile of epiderma
55 e (CLSI), U.S. Food and Drug Administration (FDA), and European Committee on Antimicrobial Susceptibi
56 , 16 by the US Food and Drug Administration (FDA), and ten by the Japan Pharmaceuticals and Medical D
58 related to the Food and Drug Administration (FDA)-approved drug fluoxetine-which also targets 2C-but
59 ilotinib, a US Food and Drug Administration (FDA)-approved drug for leukemia, indicates improvement i
60 this study, an Food and Drug Administration (FDA)-approved drug, diflunisal, was found to competitive
61 Anakinra, a US Food and Drug Administration (FDA)-approved IL-1R antagonist; or parthenolide, a caspa
63 nical-stage or Food and Drug Administration (FDA)-approved small molecules to identify candidate ther
64 lchicine, a US Food and Drug Administration (FDA)-approved treatment for inflammatory disorders that
67 CE To date, no Food and Drug Administration (FDA)-approved vaccines are available to combat hemorrhag
68 ion, but no US Food and Drug Administration (FDA)-cleared assays for detection at these sites existed
72 t-to-treat; US Food and Drug Administration [FDA] snapshot) at week 48; participant satisfaction was
73 we have compiled the structural data for all FDA Green Book drugs approved through the end of 2019.
78 RUNX1 inhibitor Ro5-3335, aflibercept-an FDA-approved vascular endothelial growth factor (VEGF) i
79 Importantly, recombinant G-CSF exists as an FDA-approved medication which may facilitate rapid clini
80 tial utility of beta-caryophyllene (BCP), an FDA-approved food additive for the treatment of CUD.
81 p21/HIF-1alpha/VEGF-A signaling with Bex, an FDA-approved drug, may increase the DTX chemo-sensitivit
83 e used digital breast tomosynthesis (DBT) an FDA approved tomographic X-ray breast imaging method as
84 r the selection of sunscreen products for an FDA-sponsored proof-of-concept maximal usage clinical tr
86 o/vivo-Clinical Data Mining), to identify an FDA-approved drug suitable for use as an effective analg
87 nhibitor, in combination with Primaxin is an FDA-approved (Recarbrio) treatment for serious and antib
92 Our results demonstrate that ivermectin, an FDA-approved antiparasitic agent, is effective at inhibi
96 liver cancer sensitivity to palbociclib, an FDA-approved CDK4 inhibitor, which was effective in trea
99 ffect that can be rescued by tigecycline, an FDA-approved drug that specifically suppresses mitochond
101 irmed in human psoriasis using vorapaxar, an FDA-approved PAR1 antagonist, on explanted lesional skin
102 , SVM, and functional discriminant analysis (FDA) models indicate that SVM is the most accurate for p
103 ral laws and FDA regulations (1962-2018) and FDA databases of approved new drugs (1984-2018), generic
105 tive SRC inhibitor has been challenging, and FDA-approved SRC inhibitors, dasatinib and bosutinib, ar
106 urveillance and allow future development and FDA regulatory approval of modernized AST to guide treat
108 evidence included principal federal laws and FDA regulations (1962-2018) and FDA databases of approve
109 the best algorithm for wildfire mapping, and FDA is the most accurate model for predicting snow avala
110 antibiotics, vancomycin and fidaxomicin, are FDA-approved for the treatment of C. difficile infection
111 ostic assays face challenges before they are FDA approved and reach the market, there are a number of
112 efficacy of auranofin (rheumatoid arthritis FDA-approved drug) in a CDI mouse model and establish an
113 nds with oncological annotations, as well as FDA-approved drugs, and identified 155 that reduced the
114 of problems, including the lack of available FDA-approved/cleared tests, limited uptake of internatio
115 primer sets and four commercially available, FDA emergency use authorized assays for SARS-CoV-2 (Ceph
118 te was mcr positive) and 12 mcr-positive CDC-FDA Antibiotic Resistance (AR) Isolate Bank isolates for
121 al and Laboratory Standards Institute (CLSI)-FDA and European Committee on Antimicrobial Susceptibili
122 reted according to the investigational CLSI, FDA, and EUCAST breakpoints, and results were compared.
125 votal clinical trials linked to contemporary FDA-approved cancer drugs, reported CVD event rates trai
128 wer limit of quantification (LOQ) of current FDA-cleared plasma HIV-1 RNA assays (20 to 40 copies/ml)
132 ions, influenza viruses resistant to current FDA antivirals have been reported and continue to emerge
137 of experiments (DOEs) using three different FDA-approved human inhaler devices followed by interacti
138 US Securities and Exchange Commission, Drugs@FDA database, and ClinicalTrials.gov, alongside publishe
140 er of PEGylated therapeutics that are either FDA-approved or in clinical development, methods that su
143 evaluate how far away we are from the first FDA-approved drug therapy for mitochondrial disease.
144 Overall, the database is insufficient for FDA approval of any psychedelic compound for routine cli
147 Adverse event information available from FDA product labels and scientific literature for drugs t
149 ical trial and another that recently garnerd FDA-approval, indicating a bright future for targeted sm
150 a high-throughput drug screen, we identified FDA-approved drugs that can suppress HIV-1 reactivation
151 a drug repositioning strategy to investigate FDA-approved gold-containing drugs against N. gonorrhoea
152 ose) polymerase (PARP) inhibitor olaparib is FDA approved for the treatment of BRCA-mutated breast, o
159 al use as a bioterrorism agent, there are no FDA-approved antivirals or vaccines for treatment or pre
164 e treatment of cuSCC, which currently has no FDA-approved targeted therapies.See related commentary b
165 been investigated, but currently there is no FDA-approved drug that can alleviate disease symptoms or
170 Despite intense research, there is still no FDA-approved medication to treat cocaine use disorder (C
176 e was previously identified from a screen of FDA-approved drugs as a potent EBOV viral entry inhibito
177 s of three steps: computational screening of FDA-approved drugs; in vitro and/or in vivo assays; and
180 l malignancies and underscore the utility of FDA-approved Trk inhibitors for patients with aggressive
184 n (rHuEPO) therapeutic protein products; one FDA-licensed rHuEPO originator biological product, three
186 tis worldwide; yet currently, no vaccines or FDA-approved antiviral drugs are available to counter th
187 entrectinib and pembrolizumab have received FDA approval for the treatment of patients with tumours
189 AM-in-CDM approach will be used to repurpose FDA-approved drugs for various new therapeutic indicatio
192 effective vaccine is available, repurposing FDA approved drugs could significantly shorten the time
194 ys (IGRAs) to receive approval from the U.S. FDA, replacing its predecessor, QuantiFERON-TB Gold In-T
198 ber of pneumonic cases of disease, we sought FDA approval of antimicrobials for treatment under the A
199 latter-phase (II and III) trials supporting FDA approval of anticancer drugs from 1998 to 2018 were
200 bolite analysis in GBM models, we found that FDA-approved global (panobinostat, vorinostat) and selec
213 The probability of a VN titer of >=160, the FDA-recommended level for convalescent plasma used for C
217 into the biology of antidepressants and the FDA approval of its s-isomer, Esketamine (Spravato), the
218 hrane Database of Systematic Reviews and the FDA drug database from inception until Nov 22, 2019 for
221 The most common biomarker approved by the FDA (United States Food and Drug Administration) is the
222 h-throughput screen of drugs approved by the FDA (US Food and Drug Administration) and identified ent
223 ur PARP inhibitors have been approved by the FDA as cancer therapeutics, yet a precise mechanistic ra
224 receptor 2 (HER2) inhibitor approved by the FDA for HER2-positive breast cancer treatment; however,
225 ral antidepressant, has been approved by the FDA for treating treatment-resistant major depressive di
227 ntifying antimicrobial drugs approved by the FDA from 2007-2016 that would likely have qualified for
229 n in 2018 and triclabendazole in 2019 by the FDA marked an important moment in the fight against dise
230 rings in small molecule APIs approved by the FDA through 2019 and show that only a few substitution p
231 s granted emergency use authorization by the FDA using nasopharyngeal swabs from symptomatic patients
233 oclonal antibody therapeutic approved by the FDA, binds to PD-1 and efficiently blocks its pathways.
234 ng on new therapeutic agents approved by the FDA, capitalized at a real cost of capital rate (the req
235 ng-term increase of neuronal activity by the FDA-approved drug 4-aminopyridine (4-AP) rescues the num
236 inhibition of TRPM7 channel activity by the FDA-approved drug FTY720 increased the sensitivity of T
237 beta MAPK-mediated activation of p300 by the FDA-approved kinase inhibitor, nilotinib, ameliorates ca
238 s of magnitude more than that induced by the FDA-approved lipid nanoparticle material MC3 in vaccinat
239 allenges of gaining clinical approval by the FDA-in particular, with regards to biological, mechanica
241 Memorial Sloan Kettering Cancer Center, the FDA, and the National Marrow Donor Program.FUNDINGThis w
242 ing MAO-A with phenelzine or clorgyline, the FDA-approved drugs for antidepression, resensitize the E
244 dent has been previously established for the FDA-approved bispecific T cell engager, blinatumomab, fo
245 lance system, the WHO VigiBase, and from the FDA Adverse Event Reporting System), 87 from Boehringer
246 ent reports for these KIs, obtained from the FDA Adverse Event Reporting System, are used to compute
247 98 from the literature search, two from the FDA homepage search, ten from the Risk Evaluation and Mi
250 phase 2 dose (RP2D, primary outcome) is the FDA/EMEA approved dose of gemcitabine-nab-paclitaxel alo
251 NMDAR antagonist NitroSynapsin, but not the FDA-approved drug memantine, abrogated this hyperactivit
252 vitro and in vivo anti-tumor effects of the FDA-approved ETAR antagonist, Ambrisentan, which is curr
253 ighlighted in the efficient synthesis of the FDA-approved therapeutic lipopeptide tesamorelin and pal
254 tes from a multicenter clinical trial of the FDA-cleared Unyvero lower respiratory tract infection (L
258 These data indicate that repurposing the FDA-approved leukemia drug, nilotinib, may be effective
259 nvestigated the potential of repurposing the FDA-approved spironolactone (SP), as one such drug.
261 is gap in knowledge and demonstrate that the FDA-approved broad-spectrum anti-infective drug nitazoxa
262 f C. difficile in vitro, suggesting that the FDA-approved formulation of UDCA, known as ursodiol, may
264 hypothesis, we make the prediction that the FDA-approved molecule, icatibant, might be able to inter
266 from six recent CABP trials submitted to the FDA (n=4,645 participants) to evaluate concordance betwe
268 free sharing of information relating to the FDA drug registration process, it will prove less daunti
269 reover, data from a phase I study led to the FDA granting breakthrough therapy designation to enfortu
270 for the sensitization of cancer cells to the FDA-approved topoisomerase inhibitors topotecan and irin
271 tinib, osimertinib) by data mining using the FDA adverse event reporting system (AERS) database, and
273 ber of antibacterial INDs initiated with the FDA from 2010-2019 was lower than any of the previous th
275 gistically improved by combining it with the FDA-approved anti-malarial, chloroquine, a known lysosom
277 ronal activity by chronic treatment with the FDA-approved potassium channel blocker 4-aminopyridine (
278 ive effects on HNSCC cells compared with the FDA-approved translation inhibitor omacetaxine mepesucci
282 ne means of treating SMA and recently led to FDA approval of an intrathecally delivered SMN-enhancing
283 ectively cover the disease module similar to FDA-approved drug combinations and could potentially sug
288 inistration of nicotine and varenicline, two FDA-approved smoking cessation aids, during abstinence),
289 n the intensive care unit, as part of the US FDA expanded access program for COVID-19 convalescent pl
291 yanine green (ICG) is the most commonly used FDA-approved agent for clinical optical imaging, adminis
294 subsequent labels of all vaccines that were FDA-approved between 1 January 1996 and 31 December 2015
295 as 96.4% and 96.6% for Enterobacterales when FDA and ISO 20776-2 criteria, respectively, were followe
297 ategies for SARS-CoV-2 serologic assays with FDA EUA are provided, as are insights into assay limitat
298 parative analysis of known SA complexes with FDA-approved drugs clearly shows that multiple medicatio