Original Post August 22, 2022 Since May 2022, an outbreak of monkeypox disease has been ongoing in multiple countries, including the United States. In the United States, monkeypox is thought to be spreading primarily through close contact with an infected, symptomatic individual. Whether, and the extent to which, monkeypox virus can be transmitted through feces…
Read MoreOriginal Post For Immediate Release: August 17, 2022 Today, the U.S. Food and Drug Administration approved Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. “Today’s approval is an important advance in the treatment of beta-thalassemia, particularly in individuals…
Read MoreOriginal Post For Immediate Release: August 10, 2022 Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s recent increased flexibilities. Company: Reckitt Nutrition/Mead Johnson Nutrition (Mexico) Product(s): Base Powder for PurAmino Hypoallergenic Infant Formula (amino acid-based…
Read MoreSun safety is always in season. It’s important to protect your skin from sun damage throughout the year, no matter the weather. Why? Sun exposure can cause sunburn, skin aging (such as skin spots, wrinkles, or “leathery skin”), eye damage, and skin cancer, the most common form of cancer in the U.S. Skin cancer is…
Read MoreOriginal Post For Immediate Release: August 09, 2022 Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the JYNNEOS vaccine to allow healthcare providers to use the vaccine by intradermal injection for individuals 18 years of age and older who are determined to be at high risk for monkeypox infection.…
Read MoreOriginal Post Date Issued: August 11, 2022 The U.S. Food and Drug Administration (FDA) is advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test, to reduce the risk an infection may be missed (false negative result) and to help prevent people from unknowingly spreading the SARS-CoV-2…
Read MoreOriginal Post For Immediate Release: August 05, 2022 Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s recent increased flexibilities. Company (Product Origin): Nestlé Health Science (The Netherlands) Product(s): Nestlé SMA Nutrition Althéra Type of…
Read MoreOriginal Post By: Robert M. Califf, M.D., Commissioner of Food and Drugs National Immunization Awareness Month provides us an opportunity to think about how far the development and advancement of immunization science has come, and its impact on public health. The U.S. Food and Drug Administration plays a key role in immunization by evaluating vaccines…
Read MoreOriginal Post For Immediate Release: July 29, 2022 Today, the U.S. Food and Drug Administration is providing an update on additional steps it has taken that will lead to more infant formula available in the U.S. under the agency’s recent increased flexibilities. Company: Danone’s Nutricia (Netherlands) Product(s): Pepticate and Pepticate Syneo Type of Formula: Specialty – Extensively Hydrolyzed Formula…
Read MoreOriginal Post For Immediate Release: July 29, 2022 Today, the U.S. Food and Drug Administration is providing an update on its multipronged response to monkeypox in the United States, including its efforts in the areas of diagnostics, vaccines and therapeutics. The agency has also established a dedicated website to provide important information about the FDA’s ongoing regulatory…
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