Results 21 to 30 of about 999,693 (251)
A review of new drugs approved by the food and drug administration in 2022
Journal of Family Medicine and Primary Care, 2023 Introduction: The drugs approved by the Food and Drug Administration (FDA) in 2022, for the first time for any indication or under any brand, were studied under the contexts of indications, mechanism of action, and side effects.
Arjun Swaminathan +2 more
doaj +1 more source
The Impasse on Overall Survival in Oncology Reimbursement Decision-Making: How Can We Resolve This?
Cancer Management and Research, 2021 Michael Patrick Lux, 1 Oriana Ciani, 2 William CN Dunlop, 3 Andrea Ferris, 4 Michael Friedlander 5 1Department of Gynecology and Obstetrics, Frauenklinik St. Louise Paderborn, St. Josefs-Krankenhaus Salzkotten, Frauen- und Kinderklinik St.
Lux MP +4 more
doaj
The challenges of access to innovative medicines with limited evidence in the European Union
Frontiers in Pharmacology, 2023 The European Medicines Agency (EMA) fosters access to innovative medicines through accelerated procedures and flexibility in the authorization requirements for diseases with unmet medical needs, such as many rare diseases as well as oncological diseases.
Antonio Vallano +7 more
doaj +1 more source
Central Asian Journal of Medical Hypotheses and Ethics, 2023 ACTH is a pituitary hormone important for proper function of adrenal glands, cortisol production as well as human physiology in general. It is involved in the pathogenesis of several endocrine disorders like Cushing syndrome and can be a useful ...
George Iliopoulos, Dimitrios Daoussis
doaj +1 more source
Current landscape of clinical development and approval of advanced therapies
Molecular Therapy: Methods & Clinical Development, 2021 Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. The uncertainty about the product's benefit-risk balance at the time of approval, the limitations of nonclinical ...
Carolina Iglesias-Lopez +3 more
doaj +1 more source
Frontiers in Pharmacology, 2021 Several advanced therapy medicinal products (ATMPs) have been approved in the European Union (EU). The aim of this study is to analyse the methodological features of the clinical trials (CT) that supported the marketing authorization (MA) of the approved
Carolina Iglesias-Lopez +5 more
doaj +1 more source
The importance of greater speed in drug development for advanced malignancies
Cancer Medicine, 2018 It takes on average 6–12 years to develop new anticancer drugs from discovery to approval. Effective new agents prolong survival. To demonstrate the importance of rapid drug approval, we calculated life‐years potentially saved if selected agents were ...
David J. Stewart +9 more
doaj +1 more source
Children, 2022 Drugs administered to children in the United States fall into two broad categories: (1) those that have followed the US Food and Drug Administration (US-FDA) pediatric drug approval process and are marketed as finished dosage forms with pediatric ...
Robert B. MacArthur +3 more
doaj +1 more source
Pediatric Blood &Cancer, EarlyView.ABSTRACT Pediatric gastroenteropancreatic neuroendocrine neoplasms (GEP‐NENs) are extremely rare and clinically heterogeneous. Management has largely been extrapolated from adult practice. This European Standard Clinical Practice Guideline (ESCP), developed by the EXPeRT network in collaboration with adult NEN experts, provides (adult) evidence ...
Michaela Kuhlen +23 more
wiley +1 more source
Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries
Revista Panamericana de Salud Pública, 2021 Objective. To describe the current status of regulatory reliance in Latin America and the Caribbean (LAC) by assessing the countries’ regulatory frameworks to approve new medicines, and to ascertain, for each country, which foreign regulators are ...
Carlos E. Durán +6 more
doaj +1 more source