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FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer

Colon

Today, the U.S. Food and Drug Administration authorized marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumors) in the colon in real time during a colonoscopy. “Artificial intelligence has the potential to transform health care to better assist health care…

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FDA Allows for First Point-of-Care Chlamydia and Gonorrhea Test to be Used in More Near-Patient Care Settings

Point-of-Care

Today, the U.S. Food and Drug Administration announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent care settings, outpatient health care facilities and other patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation. This action is the…

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FDA Approves New indication for Drug to Treat Neurogenic Detrusor Overactivity in Pediatric Patients

neurogenic

Today, the U.S. Food and Drug Administration approved a new indication for Myrbetriq (mirabegron extended-release tablets) and Myrbetriq Granules (mirabegron for extended-release oral suspension) to treat neurogenic detrusor overactivity (NDO), a bladder dysfunction related to neurological impairment, in children ages three years and older. Myrbetriq is also indicated for overactive bladder in adult patients. “Today’s action is a positive step…

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USFDA Announces New Resource for Veterinarians and Pet Owners Interested in Clinical Field Studies of Animal Cells, Tissues, and Cell- and Tissue-Based Products

animal

The following quote is attributed to Steven M. Solomon, D.V.M., M.P.H., director of the FDA’s Center for Veterinary Medicine: Veterinary regenerative medicine is a rapidly growing area of product development that offers great promise in the development of novel therapies for animals. These products, which include animal cell-based therapies such as stem cells, have the potential to repair diseased or…

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Moments in History: Patricia Bath

Bath

  Patricia Era Bath (November 4, 1942 – May 30, 2019) was an American ophthalmologist, inventor, humanitarian, and academic. She was an early pioneer of laser cataract surgery. She also became first woman member of the Jules Stein Eye Institute, first woman to lead a post-graduate training program in ophthalmology, and first woman elected to the honorary staff of the UCLA Medical Center. Bath was…

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FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV

The U.S. Food and Drug Administration approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance…

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Coronavirus (COVID-19) Update: January 22, 2021

COVID-19

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA’s Office of Criminal Investigations recently investigated a case that has led to an arrest and the filing of a criminal complaint by the U.S. Department of Justice for introducing misbranded drugs into interstate commerce. The criminal investigation found that…

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FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines

vaccine

  Two different mRNA vaccines have now shown remarkable effectiveness of about 95% in preventing COVID-19 disease in adults. As the first round of vaccine recipients become eligible to receive their second dose, we want to remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive…

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FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

Vaccine

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the…

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FDA Approved First Adjuvant Therapy for Most Common Type of Lung Cancer

Approved

The U.S. Food and Drug Administration approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation. “Today’s approval of Tagrisso demonstrates how additional research on therapies approved in later stages of cancer can eventually improve treatment options for patients in earlier stages,” said Richard Pazdur, M.D.,…

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