Results 21 to 30 of about 1,710,685 (294)

Trends in FDA drug approvals over last 2 decades: An observational study

Journal of Family Medicine and Primary Care, 2020
Introduction: The discovery of novel drugs is critical for pharmaceutical research and development as well as for patient treatment. Repurposing existing drugs that may have anticipated effects as potential candidate is one way to meet this important ...
Angelika Batta, Bhupinder Singh Kalra, Raj Khirasaria   +2 more
doaj   +1 more source

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, AE Vijayakumar, P Nikhithaa   +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, Ciani O, Dunlop WCN, Ferris A, Friedlander M   +4 more
doaj  

Overcoming the Declining Trends in Innovation and Investment in Cardiovascular Therapeutics

JACC: Basic to Translational Science, 2017
Eroom’s law (Moore’s law spelled backwards), describes adverse trends towards declining innovation and rising costs of drug development over the last several decades.
Gail A. Van Norman, MD
doaj   +1 more source

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, Antonio Vallano, Antonio Vallano, Caridad Pontes, Caridad Pontes, Caridad Pontes, Antònia Agustí, Antònia Agustí   +7 more
doaj   +1 more source

FDA-APPROVED INDICATIONS OF ADRENOCORTICOTROPIC HORMONE (ACTH) AS A DRUG: DOES IT HAVE A PLACE IN DISEASE MANAGEMENT TODAY?

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, Antonia Agustí, Antoni Vallano, Merce Obach   +3 more
doaj   +1 more source

Abiraterone acetate in metastatic castration-resistant prostate cancer after chemotherapy. A retrospective “Real Life” analysis of activity and safety [PDF]

, 2015
Abiraterone acetate (AA) is a potent, selective androge (CYP17) biosynthesis inhibitor, which showed to improve overall survival (HR = 0.646) in mCRPC patients progressing after docetaxel.
A., Giuli, A., Pellegrino, D., Santini, E. M., Ruggeri, E., Cortesi, F., Angelini, F., Longo, F., Primi, I., Sperduti, M. A., Fabbri, M. G., Chilelli, M. L., Mancini, Marchetti, Paolo, Milano, Annalisa, R., Ratta, S., Quadrini, T., Gamucci   +16 more
core   +1 more source

Methodological Characteristics of Clinical Trials Supporting the Marketing Authorisation of Advanced Therapies in the European Union

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, Antònia Agustí, Antònia Agustí, Antonio Vallano, Antonio Vallano, Merce Obach   +5 more
doaj   +1 more source

How Compounding Pharmacies Fill Critical Gaps in Pediatric Drug Development Processes: Suggested Regulatory Changes to Meet Future Challenges

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, Lisa D. Ashworth, Keming Zhan, Richard H. Parrish   +3 more
doaj   +1 more source