Alarm as FDA fast-tracks first antipsychotic drug for agitation in dementia
In trials, the antipsychotic drug brexpiprazole (Rexulti) failed to provide a clinically meaningful benefit and increased the risk of death. ...
Tag: FDA
Octapharma’s prothrombin complex concentrate, Balfaxar®, receives FDA approval for warfarin reversal in urgent surgery & invasive procedures
PARAMUS, N.J., July 26, 2023 – Octapharma USA today announced that Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and ...
Device for treating challenging bone fractures cleared by FDA
A new system for fixing bone fractures, called the Bone Bolt System, has been approved for market by the U.S. ...
Novel prostate cancer therapy receives FDA approval
SALT LAKE CITY, Utah - Neeraj Agarwal, MD, FASCO, Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, received approval by ...
MD Anderson and Replay announce FDA clearance of IND application for first-in-class TCR NK cell therapy for sarcoma
HOUSTON, SAN DIEGO and LONDON ― The University of Texas MD Anderson Cancer Center and Replay today announced that the Food ...
C-Path’s PSTC receives positive FDA response for drug-induced pancreatic injury biomarkers
Safety biomarkers aim to provide an additional tool for detecting acute drug-induced pancreatic injury (DIPI) in phase 1 clinical trials ...
Medical College of Wisconsin cancer researcher & key investigator on study of Pirtobrutinib, now FDA approved for patients previously treated for Mantle Cell Lymphoma
In a multicenter phase 1 and 2 trial (BRUIN, NCT03740529), researchers from leading cancer centers across the globe, including the ...
FDA clears bionic pancreas developed in BU Lab for people with type 1 diabetes
A bionic pancreas—a wearable, pocket-sized, automated insulin delivery device—that was first developed in a Boston University lab has been cleared ...
Investigation raises questions over lack of “substantial evidence” for FDA approved antibiotic
Drugs approved in the US require “substantial evidence” that they are effective. But an investigation by The BMJ into the recent approval ...
New device for lower extremity rehabilitation receives FDA approval!
COTRAS Co., Ltd. (hereon referred to as COTRAS), an innovative medical-device firm focused on rehabilitation products, has secured approval from ...
Octapharma USA requests FDA approval for wilate® VWD prophylaxis supplement
PARAMUS, N.J. (Feb. 23, 2023) – Octapharma USA has submitted a Biologics License Application Supplement (sBLA) to the U.S. Food ...
Mays Cancer Center led studies of innovative breast cancer drug that recently gained FDA approval
SAN ANTONIO (Feb. 1, 2023) — The Mays Cancer Center, home to UT Health San Antonio MD Anderson Cancer Center, ...
Scientists re-writes an equation in FDA guidance to improve the accuracy of the drug interaction prediction
Drugs absorbed into the body are metabolized and thus removed by enzymes from several organs like the liver. The how ...
Scientists improve the equation in FDA guidance predicting drug interactions
Drugs absorbed into the body are metabolized and thus removed by enzymes in several organs like the liver. The clearance ...
Micronoma receives FDA breakthrough device designation for OncobiotaLUNG, a novel liquid biopsy assay for lung carcinoma detection
January 10, 2023. SAN DIEGO, Calif.– Micronoma, the first biotech company offering early cancer detection with a microbiome-driven liquid biopsy ...
FDA approves “glowing tumor” imaging drug to aid lung cancer surgery
PHILADELPHIA—The U.S. Food and Drug Administration (FDA) has approved the targeted imaging agent Cytalux (pafolacianine) for use in lung cancer surgery. This ...
FDA needs to ensure that information on dense breast notifications are clear and understandable to all members of the public
(Boston)—You are among the women who dutifully gets an annual mammogram. Year after year, the results are ‘normal.’ But after ...
SafeSource Direct receives FDA clearance for American-made PPE
SafeSource Direct, LLC, the maker of high-quality, American-made personal protective equipment (PPE), announced today that its chemo-rated nitrile exam gloves ...
Investigation raises concerns about poor FDA oversight of clinical trials
Covid-19 vaccines and drugs were developed at “warp speed” and now experts are concerned about the US Food and Drug ...
Current FDA oversight of vaping industry likely to have minimal impact
Current Food and Drug Administration (FDA) oversight of the vaping industry in the US is likely to have minimal impact, ...
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Null results research now published by major behavioral medicine journal
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New findings on hair loss in men
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Tirzepatide more effective in blood sugar control and body weight loss than semaglutide, shows meta-analysis of 22 studies
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Astronomers discover newborn galaxies with the James Webb Space Telescope
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Chromosome-scale genome sequence of Suaeda glauca sheds light on salt stress tolerance in halophytes
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ISSCR Kicks off São Paulo International Symposium today in Ribeirão Preto, Brazil