Results 41 to 50 of about 4,926,176 (337)

A Significant Anticancer Drug Approval Lag Between Japan and the United States Still Exists for Minor Cancers

Clinical pharmacology and therapy, 2018
Reports have indicated that approval lag for anticancer drugs between Japan and the United States has decreased. However, if this is also true for drugs used to treat minor cancers remains unknown.
Kenji Yamashita, M. Kaneko, M. Narukawa
semanticscholar   +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, Andrew A. Stewart, Paul Wheatley‐Price, Gerald Batist, Hagop M. Kantarjian, Joan Schiller, Mark Clemons, John‐Peter Bradford, Laurel Gillespie, Razelle Kurzrock   +9 more
doaj   +1 more source

Ten‐Year Trends in Enrollment of Women and Minorities in Pivotal Trials Supporting Recent US Food and Drug Administration Approval of Novel Cardiometabolic Drugs

Journal of the American Heart Association : Cardiovascular and Cerebrovascular Disease, 2020
Background In 1993, the US Food and Drug Administration established guidelines to increase diversity by sex and race/ethnicity of participants in clinical trials supporting novel drug approvals.
M. Khan, Izza Shahid, T. Siddiqi, Safi U. Khan, Haider J. Warraich, S. Greene, J. Butler, E. Michos   +7 more
semanticscholar   +1 more source

A Quality Improvement Initiative to Standardize Pneumocystis jirovecii Pneumonia Prophylaxis in Pediatric Patients With Solid Tumors

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background Pediatric patients with extracranial solid tumors (ST) receiving chemotherapy are at an increased risk for Pneumocystis jirovecii pneumonia (PJP). However, evidence guiding prophylaxis practices in this population is limited. A PJP‐related fatality at our institution highlighted inconsistent prescribing approaches and concerns about
Kriti Kumar, Denise M. Connolly, Ellen Kellington, Elyse Zelunka, Karla Kerrigan, Furqan Shaikh, Paul C. Nathan, Meredith S. Irwin, Sarah Cohen‐Gogo   +8 more
wiley   +1 more source

How to use FDA drug approval documents for evidence syntheses

British medical journal, 2018
Evidence syntheses may benefit from using aggregated clinical trial information in approval documents published online by the US Food and Drug Administration (FDA).
Aviv Ladanie, Hannah Ewald, B. Kasenda, L. Hemkens   +3 more
semanticscholar   +1 more source

Pazopanib Combined With Vincristine and Irinotecan in Relapsed Wilms Tumor: Encouraging Outcomes in a Heavily Pretreated Pediatric Cohort

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Background While Wilms tumor (WT) typically has a favorable prognosis, relapsed cases—especially those with high‐risk histology—remain therapeutically challenging after intensive frontline therapy. The combination of vincristine and irinotecan has demonstrated activity in pediatric solid tumors, and pazopanib, a multi‐targeted tyrosine kinase ...
Maria Debora De Pasquale, Alessandro Crocoli, Giuseppe Maria Milano, Pierluigi Di Paolo, Francesca Diomedi Camassei, Ida Russo, Annalisa Serra   +6 more
wiley   +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

Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016

JAMA Network Open, 2020
Key Points Question What are the available data on cancer treatment outcomes for new cancer therapies approved by the US Food and Drug Administration?
Aviv Ladanie, A. Schmitt, B. Speich, F. Naudet, A. Agarwal, Tiago V. Pereira, F. Sclafani, A. Herbrand, M. Briel, J. Martín-Liberal, Thomas Schmid, Hannah Ewald, J. Ioannidis, H. Bucher, B. Kasenda, L. Hemkens   +15 more
semanticscholar   +1 more source

Nutritional and Behavioral Intervention for Long‐Term Childhood Acute Leukemia Survivors With Metabolic Syndrome

Pediatric Blood &Cancer, EarlyView.
ABSTRACT Purpose Metabolic syndrome (MetS) is a common complication in survivors of childhood acute lymphoblastic and myeloid leukemia (AL), and a major risk factor for premature cardiovascular disease, type‐2‐diabetes, and metabolic dysfunction‐associated steatotic liver disease (MASLD).
Visentin Sandrine, Béliard Sophie, Renard Cécile, Caussy Cyrielle, Hamidou Zeinab, Romano David, Gacem Mélanie, Petit Arnaud, Saultier Paul, Borentain Patrick, Michel Gérard   +10 more
wiley   +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