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Management: Food and Drug Administration (FDA)
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Use of Nirsevimab for the Prevention of Respiratory Syncytial Virus Disease Among Infants and Young Children: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023
MMWR Morb Mortal Wkly Rep. 2023 Aug 25;72(34):920-925. doi: 10.15585/mmwr.mm7234a4.ABSTRACTRespiratory syncytial virus (RSV) is the leading cause of hospitalization among U.S. infants. In July 2023, the Food and Drug Administration approved nirsevimab, a long-acting monoclonal antibody, for passive immunization to prevent RSV-associated lower respiratory tract infection among infants and young children. Since October 2021, the Advisory Committee on Immunization Practices (ACIP) Maternal and Pediatric RSV Work Group has reviewed evidence on the safety and efficacy of nirsevimab among infants and young children. On August 3,...
Source: MMWR Morb Mortal Wkl... - August 24, 2023 Category: Epidemiology Authors: Jefferson M Jones Katherine E Fleming-Dutra Mila M Prill Lauren E Roper Oliver Brooks Pablo J S ánchez Camille N Kotton Barbara E Mahon Sarah Meyer Sarah S Long Meredith L McMorrow Source Type: research
FDA Approval Summary: Dabrafenib in combination with trametinib for BRAF V600E mutation-positive low-grade glioma
Clin Cancer Res. 2023 Aug 23:CCR-23-1503. doi: 10.1158/1078-0432.CCR-23-1503. Online ahead of print.ABSTRACTOn March 16, 2023, the U.S. Food and Drug Administration (FDA) approved dabrafenib in combination with trametinib (Tafinlar®, Mekinist®, Novartis Pharmaceuticals Corporation) for the treatment of pediatric patients with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. FDA also approved oral formulations of both drugs suitable for patients who cannot swallow pills. This approval was based on the LGG cohort from Study CDRB436G2201 (NCT02684058), a multicenter, open-label trial in which ...
Source: Clinical Cancer Research - August 23, 2023 Category: Cancer & Oncology Authors: Michael I Barbato Jeannette Nashed Diana Bradford Yi Ren Sachia Khasar Claudia P Miller Banu S Zolnik Hong Zhao Yangbing Li Youwei Bi Stacy S Shord Anup K Amatya Pallavi S Mishra-Kalyani Barbara Scepura Raniya A Al-Matari Richard Pazdur Paul G Kluetz Mart Source Type: research
Current status of skin cancers with a focus on immunology and immunotherapy
Cancer Cell Int. 2023 Aug 21;23(1):174. doi: 10.1186/s12935-023-03012-7.ABSTRACTSkin cancer is one of the most widespread cancers, with a significant global health effect. UV-induced DNA damage in skin cells triggers them to grow and proliferate out of control, resulting in cancer development. Two common types of skin cancer include melanoma skin cancer (MSC) and non-melanoma skin cancer (NMSC). Melanoma is the most lethal form of skin cancer, and NMSC includes basal cell carcinoma (BCC), squamous cell carcinoma (SCC), and other forms. The incidence of skin cancer is increasing in part owing to a demographic shift toward a...
Source: Cancer Control - August 22, 2023 Category: Cancer & Oncology Authors: Mahsa Khayyati Kohnehshahri Aila Sarkesh Leila Mohamed Khosroshahi Zanyar HajiEsmailPoor Ali Aghebati-Maleki Mehdi Yousefi Leili Aghebati-Maleki Source Type: research
The Regulatory Repercussions of Approving Muscular Dystrophy Medications on the Basis of Limited Evidence
Ann Intern Med. 2023 Aug 22. doi: 10.7326/M23-1073. Online ahead of print.ABSTRACTThe U.S. Food and Drug Administration (FDA) approved eteplirsen (Exondys 51) for Duchenne muscular dystrophy in 2016 via its accelerated approval program on the basis of a study of 12 boys. After a contentious review process and a high-profile meeting of an external advisory committee, FDA leaders concluded that very small increases in treated patients' levels of dystrophin, a muscle protein, were reasonably likely to predict clinical benefit. The eteplirsen approval, which was followed by approvals of other drugs in the same class via the sa...
Source: Annals of Internal Medicine - August 21, 2023 Category: Internal Medicine Authors: Liam Bendicksen Diana M Zuckerman Jerry Avorn Sophia Phillips Aaron S Kesselheim Source Type: research
Simultaneous administration of mRNA COVID-19 bivalent booster and influenza vaccines
We describe simultaneous influenza and mRNA COVID-19 bivalent booster vaccine administration between August 31-December 31, 2022, among persons aged ≥6 months in the Vaccine Safety Datalink (VSD) by COVID-19 bivalent booster vaccine type, influenza vaccine type, age group, sex, and race and ethnicity. Of 2,301,876 persons who received a COVID-19 bivalent booster vaccine, 737,992 (32.1%) received simultaneous influenza vaccine, majority were female (53.1%), aged ≥18 years (91.4%), and non-Hispanic White (55.7%). These findings can inform future VSD studies on simultaneous influenza and COVID-19 bivalent booster vaccine ...
Source: Vaccine - August 20, 2023 Category: Allergy & Immunology Authors: Tat'Yana A Kenigsberg Kristin Goddard Kayla E Hanson Ned Lewis Nicola Klein Stephanie A Irving Allison L Naleway Bradley Crane Tia L Kauffman Stanley Xu Matthew F Daley Laura P Hurley Robyn Kaiser Lisa A Jackson Amelia Jazwa Eric S Weintraub Source Type: research
