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FDA Issues Landmark Proposal to Improve Access to Hearing Aid Technology for Millions of Americans

hearing aid

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 rule would allow hearing aids…

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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 second interchangeable biosimilar product approved…

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FDA to Hold Advisory Committee Meeting to Discuss Merck and Ridgeback’s EUA Application for COVID-19 Oral Treatment

pill

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 use of molnupiravir to treat…

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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 and found evidence to support…

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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 facing a growing epidemic of…

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Living Minute Series – Making Strides Against Breast Cancer

South Florida PBS’ Health Channel is highlighting innovations in Breast Cancer in its Living Minute Series, featuring clinical advances that may soon translate into improved care, cutting-edge technology and treatments that are fueling progress. The Living Minute series consists of one-minute daily reports infused with health and hope covering a range of topics. Reports air on South Florida PBS’ channels, WPBT, WXEL and Health Channel and are shared on social media @AllHealthGo and digital platforms (www.livingminute.tv.) Every…

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FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency

Agency Also Denies Applications for Flavored Products for Failing to Demonstrate that Marketing of These Products Would Be Appropriate for the Protection of Public Health Today, the U.S. Food and Drug Administration announced it has authorized the marketing of three new tobacco products, marking the first set of electronic nicotine delivery system (ENDS) products ever to be authorized by the FDA through…

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The 2021 Taurid Meteor Shower Starting tonight…

  The Southern Taurids can be seen tonight. The Taurids are an annual meteor shower, associated with the comet Encke. The Taurids are actually two separate showers, with a Southern and a Northern component. The Southern Taurids originated from Comet Encke, while the Northern Taurids originated from the asteroid 2004 TG10 They are named after their radiant point in the constellation Taurus, where they are seen to come from…

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The Best Trans-Friendly Laser Hair Removal Of 2021 Is At Seattle Plastic Surgery

Laser hair removal can sometimes require treating sensitive areas and some understandable apprehension. Considering that Brazilian laser hair removal procedures are among the most popular, it explains why this nearly painless and quick treatment can cause distress. This stress is only heightened for transgender patients who may experience dysphoria surrounding their bodies and unwanted body hair. Laser hair removal often aids…

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FDA Approves Innovative Treatment for Pediatric Patients with Congenital Athymia

  Today, the U.S. Food and Drug Administration approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder. Rethymic is the first thymus tissue product approved in the U.S. “Today’s action marks the first FDA approval of a therapy to treat this very rare and devastating disease in children,” said Peter Marks, M.D., Ph.D., director…

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