Category: health and wellness
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FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age
Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted…
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FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants
FDA adds restrictions and approves new labeling for all approved breast implants Today, the FDA took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions. First, the agency issued orders restricting the sale and distribution of breast implants to help ensure that patients considering…
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U.S. CDC Advisory Committee Unanimously Recommends Johnson & Johnson COVID-19 Vaccine as a Booster
Johnson & Johnson (the Company) (NYSE: JNJ) today announced that the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), has recommended its COVID-19 vaccine as a booster for all eligible individuals who receive an authorized COVID-19 vaccine. “Today’s recommendation supports the use of the Johnson & Johnson COVID-19 vaccine…
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Topgolf Tees Off Construction Of New Venue Serving Durham & Raleigh
Topgolf to be part of major development as it prepares to open third venue in North Carolina Topgolf Entertainment Group, a global sports and entertainment company, announced today it has officially kicked off development efforts for a new venue to serve all communities of the Durham and Raleigh areas in North Carolina. Construction on the new, three-level, 102-bay venue is…
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FDA Permits Marketing of New Oral Tobacco Products through Premarket Tobacco Product Application Pathway
Photo by Ivan Samkov from Pexels Data Show Youth, Non-Smokers, and Former Smokers Are Unlikely to Initiate or Reinitiate Tobacco Use with These Products Today, the U.S. Food and Drug Administration announced it has authorized the marketing of four new oral tobacco products manufactured by U.S. Smokeless Tobacco Company LLC under the brand name of Verve. Based…
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FDA Issues Landmark Proposal to Improve Access to Hearing Aid Technology for Millions of Americans
Proposed Rule Would Establish New Category of Over-the-Counter Hearing Aids Today, the U.S. Food and Drug Administration issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of Americans. The agency proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the…
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FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira
Second Interchangeable Biosimilar Product Approved by Agency The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be substituted for), its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the…
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FDA to Hold Advisory Committee Meeting to Discuss Merck and Ridgeback’s EUA Application for COVID-19 Oral Treatment
Today, the U.S. Food and Drug Administration is announcing an upcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss Merck and Ridgeback’s request for an emergency use authorization (EUA) for molnupiravir, an investigational antiviral drug to treat COVID-19. On Nov. 30, the advisory committee will meet to discuss the available data supporting the…
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Is CBD Oil Really Effective? Studies Would Suggest So
Is CBD Oil Really Effective? Studies Would Suggest So By Gayle Jacobson Many claims are made about CBD oil’s ability to relieve pain, anxiety, MS symptoms, colds, and arthritis. But does CBD oil really work? Is CBD oil able to treat the symptoms of many diseases, illnesses and injuries? We have investigated this issue…
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To Improve Nutrition and Reduce the Burden of Disease, FDA Issues Guidance for Voluntarily Reducing Sodium in Processed and Packaged Foods
The following is attributed to Acting FDA Commissioner Janet Woodcock, M.D., and Susan T. Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition A cornerstone of the U.S. Food and Drug Administration’s public health mission is to reduce the burden of chronic disease through improved nutrition. As a nation, we are…