Results 201 to 210 of about 5,669 (241)
In the EU, conditional marketing authorization is a pragmatic tool for early approval of a medicine that fulfills an unmet medical need. In the pharmaceutical legislation, an unmet medical need means that a condition lacks a satisfactory method for diagnosis, prevention, or treatment.
Florian Lasch+2 more
wiley +1 more source
Japan's conditional/time‐limited early approval program, initiated in 2014, aimed to advance regenerative medicine by expediting market access. However, the withdrawal of autologous skeletal myoblast sheets (Heartsheet) due to ineffectiveness raises concerns about the balance between rapid approval and scientific integrity.
Hayase Hakariya+3 more
wiley +1 more source
A Half-Century of Heterotopic Heart Transplantation in Mice: The Spearhead of Immunology Research
Decheng Yin+8 more
openalex +1 more source
A compilation of factors over the past decade—including the availability of increasingly large and rich healthcare datasets, advanced technologies to extract unstructured information from health records and digital sources, advancement of principled study design and analytic methods to emulate clinical trials, and frameworks to support transparent ...
Rohini K. Hernandez+14 more
wiley +1 more source
Editorial: Immunology of allogeneic hematopoietic stem cell transplantation
Carmelo Gurnari+3 more
openalex +1 more source
Platelet reconstitution after allogeneic hematopoietic cell transplantation (allo‐HCT) is heterogeneous and influenced by various patient‐ and transplantation‐related factors, associated with poor prognoses for poor graft function (PGF) and isolated thrombocytopenia.
Katharina M. Götz+23 more
wiley +1 more source
Concept of methylprednisolone chronotherapy to prevent acute rejections. While endogenous cortisol secretion rises in the early morning, the number of lymphocytes in the blood is higher at night, thus exhibiting an antiphase pattern to cortisol secretion. Therefore, compared with the daytime, the infiltration of lymphocytes into immune‐reactive tissues
Kentaro Ushijima+11 more
wiley +1 more source