Food and Drug Administration (FDA) Research This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Methods to derive a modified mayo score from electronic health records data
The modified Mayo Score (MMS), which consists of stool frequency, rectal bleeding, and endoscopic subscores, is the most commonly used method for measuring disease activity in Ulcerative Colitis (UC) patients. It is a standard outcome measure in clinical trials, and is recommended as a clinical trial endpoint by the US Food and Drug Administration. Each component has a score from 0-3; the total MMS ranges from 0 to 9. MMS is infrequently recorded in routine care, in part because it requires an endoscopic assessment. (Source: Gastroenterology)
Source: Gastroenterology - March 31, 2023 Category: Gastroenterology Authors: Anna Swenson, Kristin Burke, Katherine Womack, Meaghan Quinn, Gary Curhan Tags: Disease Activity Assessment Source Type: research

FDA Approves Naloxone Nasal Spray for Over-the-Counter Sale
The U.S. Food and Drug Administration (FDA) yesterdayapproved Narcan (naloxone) 4 mg hydrochloride nasal spray for purchase without a prescription. Narcan rapidly reverses the effects of an opioid overdose.“Naloxone is a critical tool in addressing opioid overdoses, and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in an FDA news release.The FDA ’s action “paves the way” for Narcan to be sold in drugstores, supermarkets, convenience stores, gas stations, ...
Source: Psychiatr News - March 30, 2023 Category: Psychiatry Tags: APA Emergent BioSolutions FDA Food and Drug Administration naloxone narcan opioid overdose OTC over the counter medication Robert Califf substance use disorder Source Type: research

JYNNEOS Vaccination Coverage Among Persons at Risk for Mpox - United States, May 22, 2022-January 31, 2023
MMWR Morb Mortal Wkly Rep. 2023 Mar 31;72(13):342-347. doi: 10.15585/mmwr.mm7213a4.ABSTRACTFrom May 2022 through the end of January 2023, approximately 30,000 cases of monkeypox (mpox) have been reported in the United States and >86,000 cases reported internationally.* JYNNEOS (Modified Vaccinia Ankara vaccine, Bavarian Nordic) is recommended for subcutaneous administration to persons at increased risk for mpox (1,2) and has been demonstrated to provide protection against infection (3-5). To increase the total number of vaccine doses available, the Food and Drug Administration (FDA) issued an Emergency Use Authorization...
Source: MMWR Morb Mortal Wkl... - March 30, 2023 Category: Epidemiology Authors: Lauren E Owens Dustin W Currie Ellen A Kramarow Safana Siddique Megan Swanson Rosalind J Carter Jennifer L Kriss Peter M Boersma Florence C Lee Ian Spicknall Elizabeth Hurley Maria Zlotorzynska Adi V Gundlapalli Source Type: research

Overview of Safety, Efficacy, and Patient Counseling for Ruxolitinib in Treating Atopic Dermatitis
Skinmed. 2023 Mar 29;21(1):40-43. eCollection 2023.ABSTRACTRuxolitinib, a Janus kinase (JAK) inhibitor, has been used orally for over a decade in the treatment of myelofibrosis. The immunosuppressive and anti-inflammatory properties of ruxolitinib have made it an attractive treatment option for several dermatologic conditions, such as atopic dermatitis, psoriasis, alopecia areata, and vitiligo. In October 2021, US Food and Drug Administration approved ruxolitinib as the first topical JAK inhibitor for treating atopic dermatitis. Recent studies have demonstrated its efficacy for both visible manifestations and itch of atopi...
Source: Skinmed - March 29, 2023 Category: Dermatology Authors: Elizabeth Mancuso-Stewart Jaimie Rodger Matthew Zirwas Source Type: research

FDA analysis of ineligibility for acute myeloid leukemia clinical trials by race and ethnicity
The objective of this study was to analyze the rates and reasons for trial ineligibility by race and ethnicity in trials of acute myeloid leukemia (AML) submitted to the U.S. Food and Drug Administration (FDA) between 2016-2019. (Source: Clinical Lymphoma, Myeloma and Leukemia)
Source: Clinical Lymphoma, Myeloma and Leukemia - March 29, 2023 Category: Hematology Authors: Dianne Pulte, Laura Fernandes, Guo Wei, Ashley Woods, Kelly J. Norsworthy, Nicole Gormley, Bindu Kanapuru, Thomas E. Gwise, Richard Pazdur, Julie Schneider, Marc R. Theoret, Lola A. Fashoyin-Aje, R. Angelo de Claro Tags: Original Study Source Type: research

An Unusual Case of Hemophagocytic Lymphohistiocytosis Associated with < em > Mycobacterium chimaera < /em > or Large-Cell Neuroendocrine Carcinoma
We present a 56-year-old patient who was admitted with worsening weakness, exertional dyspnea, dry and nonproductive cough, and a 5-pound weight loss associated with loss of appetite. This is among the rare disorders that are not commonly encountered in day-to-day practice. Our differential diagnoses were broad, including infection, such as visceral leishmaniasis, atypical/tuberculous mycobacteria, histoplasmosis, Ehrlichia, Bartonella, Brucella, Adenovirus, disseminated herpes simplex virus (HSV), hematological-like Langerhans cell histiocytosis, or multicentric Castleman disease; drug reaction, such as drug rash with eos...
Source: Current Oncology - March 28, 2023 Category: Cancer & Oncology Authors: Tejaswi Venigalla Sheila Kalathil Meena Bansal Mark Morginstin Vinicius Jorge Patricia Perosio Source Type: research

Ki67 in Breast Cancer Assay: An Ad Hoc Testing Recommendation from the Canadian Association of Pathologists Task Force
Curr Oncol. 2023 Mar 6;30(3):3079-3090. doi: 10.3390/curroncol30030233.ABSTRACTKi67, a marker of cellular proliferation, is commonly assessed in surgical pathology laboratories. In breast cancer, Ki67 is an established prognostic factor with higher levels associated with worse long-term survival. However, Ki67 IHC is considered of limited clinical use in breast cancer management largely due to issues related to standardization and reproducibility of scoring across laboratories. Recently, both the American Food and Drug Administration (FDA) and Health Canada have approved the use of abemaciclib (CDK4/6 inhibitor) for patien...
Source: Current Oncology - March 28, 2023 Category: Cancer & Oncology Authors: Hala Faragalla Anna Plotkin Penny Barnes Fang-I Lu Zuzana Kos Anna Marie Mulligan Anita Bane Sharon Nofech Mozes Source Type: research

Contributions of the Department of Defense Congressionally Directed Medical Research Programs to Advances in Cancer Therapeutics
Mil Med. 2023 Mar 28:usad089. doi: 10.1093/milmed/usad089. Online ahead of print.ABSTRACTNearly a billion dollars is spent annually in the Military Health System (MHS) on cancer diagnosis and treatment, with a large portion of that directed toward breast, prostate, and ovarian cancers. Multiple studies have demonstrated the impact of specific cancers on MHS beneficiaries and Veterans, highlighting the fact that active duty and retired military members have a higher incidence than the general public for many chronic diseases and certain forms of cancer. The Congressionally Directed Medical Research Programs have supported r...
Source: Military Medicine - March 28, 2023 Category: International Medicine & Public Health Authors: Melanie Neagley Alexis Helsel Regina Buachie Tracy Behrsing Sagar Ghosh Gayle Vaday Melissa D Cunningham Source Type: research

Ki67 in Breast Cancer Assay: An Ad Hoc Testing Recommendation from the Canadian Association of Pathologists Task Force
Curr Oncol. 2023 Mar 6;30(3):3079-3090. doi: 10.3390/curroncol30030233.ABSTRACTKi67, a marker of cellular proliferation, is commonly assessed in surgical pathology laboratories. In breast cancer, Ki67 is an established prognostic factor with higher levels associated with worse long-term survival. However, Ki67 IHC is considered of limited clinical use in breast cancer management largely due to issues related to standardization and reproducibility of scoring across laboratories. Recently, both the American Food and Drug Administration (FDA) and Health Canada have approved the use of abemaciclib (CDK4/6 inhibitor) for patien...
Source: Cancer Control - March 28, 2023 Category: Cancer & Oncology Authors: Hala Faragalla Anna Plotkin Penny Barnes Fang-I Lu Zuzana Kos Anna Marie Mulligan Anita Bane Sharon Nofech Mozes Source Type: research

An Unusual Case of Hemophagocytic Lymphohistiocytosis Associated with < em > Mycobacterium chimaera < /em > or Large-Cell Neuroendocrine Carcinoma
We present a 56-year-old patient who was admitted with worsening weakness, exertional dyspnea, dry and nonproductive cough, and a 5-pound weight loss associated with loss of appetite. This is among the rare disorders that are not commonly encountered in day-to-day practice. Our differential diagnoses were broad, including infection, such as visceral leishmaniasis, atypical/tuberculous mycobacteria, histoplasmosis, Ehrlichia, Bartonella, Brucella, Adenovirus, disseminated herpes simplex virus (HSV), hematological-like Langerhans cell histiocytosis, or multicentric Castleman disease; drug reaction, such as drug rash with eos...
Source: Herpes - March 28, 2023 Category: Infectious Diseases Authors: Tejaswi Venigalla Sheila Kalathil Meena Bansal Mark Morginstin Vinicius Jorge Patricia Perosio Source Type: research