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1.
The European medicines agency review of pomalidomide in combination with low-dose dexamethasone for the treatment of adult patients with multiple myeloma: summary of the scientific assessment of the committee for medicinal products for human use.
Oncologist
; 20(3): 329-34, 2015 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-25673103
2.
The European medicines agency review of bosutinib for the treatment of adult patients with chronic myelogenous leukemia: summary of the scientific assessment of the committee for medicinal products for human use.
Oncologist
; 19(4): 421-5, 2014 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-24668331
3.
Considering Global Development? Insights from Applications for FDA Breakthrough Therapy and EMA PRIME Designations.
Ther Innov Regul Sci
; 57(2): 321-328, 2023 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-36307671
4.
A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014-2016: Concordance, Discordance, and Why.
Clin Pharmacol Ther
; 107(1): 195-202, 2020 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-31306483
5.
The European Medicines Agency review of ipilimumab (Yervoy) for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy: summary of the scientific assessment of the Committee for Medicinal Products for Human Use.
Eur J Cancer
; 48(2): 237-42, 2012 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-22030452
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