Results for: FDA

Despite acknowledging that evidence is limited, the U.S. Food and Drug Administration (FDA) has allowed yogurt producers to make the claim that yogurt can reduce the risk of Type 2 diabetes. This decision has sparked debate, with some experts questioning the validity of the claim. The FDA classifies such claims as “qualified health claims,” which lack full scientific support but are permitted with disclaimers to prevent misleading consumers. Critics argue that the claim is not supported by rigorous scientific evidence, and that promoting yogurt consumption could inadvertently increase the risk of diabetes due to added sugars and unhealthy mix-ins.

According to the Food and Drug Administration (FDA), approximately one in five retail samples of commercial milk have exhibited traces of bird flu. This follows the initial detection of avian flu in Texan herds in March, which has since spread to over three dozen herds across eight states. However, the FDA emphasizes that milk remains safe to consume, based on current retail milk studies. To address the ongoing outbreak, dairy cattle must now undergo testing and receive negative results before crossing state lines. Herds carrying the virus have been identified in Idaho, Kansas, Michigan, New Mexico, North Carolina, Ohio, Texas, and South Dakota. The FDA also reports that egg producers are on high alert after chickens tested positive for the virus in Texas and Michigan, but the risk of human infection remains low.

The Food and Drug Administration (FDA) has identified traces of the H5N1 bird flu virus in one out of five milk samples collected from retail stores nationwide. This finding suggests a wider prevalence of the virus than previously detected, raising concerns among scientists and health experts. Despite the positive test results, the FDA emphasizes that there is no immediate risk to consumers, as investigations by National Institutes of Health-funded researchers indicate the absence of infectious virus in the milk supply.

The U.S. Department of Agriculture has mandated that all dairy cows transported across state lines be tested for bird flu. This comes after the Food and Drug Administration detected fragments of the virus in pasteurized milk samples. The FDA, in collaboration with the USDA, is conducting a nationwide survey to locate the source of the contaminated milk. Despite directives to discard sick cows’ milk and test symptomatic ones, the virus’s presence in the commercial milk supply indicates these measures were insufficient. Scientists are uncertain about the virus’s prevalence and duration, raising concerns about its potential spread. The CDC emphasizes that despite the H5N1 strain’s severity in humans, there is no current threat to public health, with only one reported mild case in a Texas dairy worker.

The Food and Drug Administration (FDA) has detected genetic material from the bird flu virus in pasteurized milk. However, the FDA emphasizes that this discovery does not indicate the presence of infectious virus and that the milk supply remains safe for consumption. The FDA is conducting further tests to confirm its findings. The risk of infection from milk with viral fragments is considered negligible as the genetic material cannot replicate independently.

The U.S. Food and Drug Administration (FDA) has approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae. Uncomplicated UTIs are bacterial infections of the bladder in females with no structural abnormalities of their urinary tract. Approximately one-half of all women experience at least one UTI in their lifetime.

The Food and Drug Administration (FDA) announced this week that genetic evidence of the H5N1 bird flu virus was found in pasteurized milk sold in the United States. This discovery raised concerns about the safety of milk products, prompting many consumers to wonder what this means for their health.

The U.S. Department of Agriculture (USDA) implemented a federal order requiring negative H5N1 bird flu virus tests for interstate cattle movement, laboratory reporting for positive cases, and herd investigations in infected farms. The order applies to lactating dairy cows initially. The Food and Drug Administration (FDA) confirmed H5N1 RNA traces in milk products but emphasized that pasteurization eliminates the virus. Research suggests the PCR-positive milk may not contain live viruses. The National Institutes of Allergy and Infectious Diseases (NIAID) supports the findings. Despite resistance from some farmers, the USDA aims to improve information gathering and access with the order. The Centers for Disease Control and Prevention (CDC) faces challenges in investigating worker health on infected farms but explores wastewater surveillance for H5N1 detection.

HOOKIPA Pharma Inc. (HOOK) has received clearance from the FDA for its Investigational New Drug (IND) application for HB-700, a novel arenaviral therapeutic vaccine for the treatment of KRAS-mutated cancers. The HB-700 program is designed to treat KRAS-mutated lung, colorectal, pancreatic, and other cancers by targeting the five most prevalent KRAS mutations in these disease indications: G12D, G12V, G12R, G12C, and G13D. The company says the program can benefit more patients than single mutation inhibitors. The IND submission achieves a final $10 million milestone payment from Roche Holdings AG (RHHBY). Effective April 25, 2024, the company will regain full control of the associated intellectual property portfolio and have full collaboration and licensing rights for the HB-700 program. The company will publish preclinical data in an abstract at the American Society for Clinical Oncology (ASCO) 2024 Annual Meeting.

The U.S. Food and Drug Administration (FDA) has revealed the presence of remnants of the bird flu virus in pasteurized milk samples. However, the agency emphasizes that the material is inactivated and poses no risk to consumers. The FDA continues to investigate the issue and has not identified any changes to its assessment of the safety of the commercial milk supply. The detection comes after the highly pathogenic avian influenza virus infected dairy cows in multiple states. Officials are conducting additional tests to determine the extent of the findings and assess any potential risks.