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U.S. FDA Approval Summary: Nivolumab for Treatment of Unresectable or Metastatic Melanoma Following Progression on Ipilimumab.
Clin Cancer Res. 2017 Jul 15;23(14):3484-3488. doi: 10.1158/1078-0432.CCR-16-0712. Epub 2017 Jan 13.
Clin Cancer Res. 2017.
PMID: 28087644
Clinical Trial.
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma.
Chuk MK, Chang JT, Theoret MR, Sampene E, He K, Weis SL, Helms WS, Jin R, Li H, Yu J, Zhao H, Zhao L, Paciga M, Schmiel D, Rawat R, Keegan P, Pazdur R.
Chuk MK, et al. Among authors: weis sl.
Clin Cancer Res. 2017 Oct 1;23(19):5666-5670. doi: 10.1158/1078-0432.CCR-16-0663. Epub 2017 Feb 24.
Clin Cancer Res. 2017.
PMID: 28235882
Clinical Trial.
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Clinical pharmacology considerations for first-in-human clinical trials for enzyme replacement therapy.
Stern S, Wang J, Li RJ, Hon YY, Weis SL, Wang YC, Schuck R, Pacanowski M.
Stern S, et al. Among authors: weis sl.
J Inherit Metab Dis. 2024 May 13. doi: 10.1002/jimd.12746. Online ahead of print.
J Inherit Metab Dis. 2024.
PMID: 38740427
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Regulatory news: Cipaglucosidase alfa-atga (Pombiliti) coadministered with Miglustat (Opfolda) for adults with late-onset Pompe disease.
Luquetti DV, Jeng LJB, Donohue KM, Maynard JW; Review Team.
Luquetti DV, et al.
J Inherit Metab Dis. 2024 May 20. doi: 10.1002/jimd.12744. Online ahead of print.
J Inherit Metab Dis. 2024.
PMID: 38768612
No abstract available.
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Alternatives to Monkey Reproductive Toxicology Testing for Biotherapeutics.
Hoberman AM, Maki K, Mikashima F, Naota M, Wange RL, Lansita JA, Weis SL.
Hoberman AM, et al. Among authors: weis sl.
Int J Toxicol. 2023 Dec;42(6):467-479. doi: 10.1177/10915818231200859. Epub 2023 Sep 15.
Int J Toxicol. 2023.
PMID: 37714565
Review.
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