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FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer

non-small cell lung cancer

The U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The FDA also approved the Guardant360 CDx (Guardant Health Inc.) as a companion diagnostic for Rybrevant today. “Advances in precision oncology continue…

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FDA Approves Treatment for Chronic Kidney Disease

kidney

Approval is First to Cover Many Causes of Disease The U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression. “Chronic kidney disease is an important public health issue, and…

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FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers

Smokers

Efforts to ban menthol cigarettes, ban flavored cigars build on previous flavor ban and mark significant steps to reduce addiction and youth experimentation, improve quitting, and address health disparities The U.S. Food and Drug Administration announced it is committing to advancing two tobacco product standards to significantly reduce disease and death from using combusted tobacco products, the leading cause of…

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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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