Regenxbio announces FDA review extension for RGX-121 BLA
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Los Angeles Times
17 minutes ago
- Los Angeles Times
LA Times Today: FDA panel on the use of antidepressants during pregnancy is alarming experts
Data shows as many as 20 percent of women experience depression during pregnancy. And in the first year after giving birth, suicide is a leading cause of death for an FDA panel recently attacked SSRI's – a class of antidepressant drugs – and their use during pregnancy. Some doctors say the panel is spreading misinformation about the drugs. L.A. Times science and medicine reporter Corinne Purtill joined Lisa McRee to explain.
The Hill
17 minutes ago
- The Hill
HHS will allow emergency use of animal drugs in New World screwworm fight
The Food and Drug Administration (FDA) became authorized on Tuesday to allow the use of animal drugs to treat or prevent infestations caused by the New World screwworm, a flesh-eating parasite that has recently disrupted the cattle industry. A declaration from the Department of Health and Human Services (HHS) will allow the FDA to issue emergency use authorizations for animal drugs to treat the insect. A spokesperson for HHS did not specify what medicines have been green-lit to combat the parasite. 'Our priority is to safeguard both animal health and the nation's food supply,' said FDA Commissioner Marty Makary. ' FDA is acting swiftly and responsibly to help ensure we have the necessary tools to prevent and control New World Screwworm, minimizing risks to agriculture and public health.' New World screwworms are a type of fly that lay their eggs in warm-blooded animals like cattle, horses, deer and even household pets like cats and dogs, according to the Department of Agriculture (USDA). Once the eggs hatch, the larvae can cause deadly damage to animals as they burrow into open wounds to feed on living tissue. In rare cases, the bugs have been known to attack humans, but HHS said in a statement that the current risk to human health in the U.S. 'remains very low.' But the potential future threat to animals and the country's food supply chain requires proactive action. USDA announced in May it would suspend all cattle, horse, and bison imports from Mexico after the bug was detected about 700 miles from the U.S. border in animals in Oaxaca and Veracruz. There are no FDA-approved drugs to treat the parasite in the U.S., but the agency can authorize the 'flexible, faster use' of certain animal drug products approved for other purposes or available in other countries under an emergency use authorization, according to a statement from HHS. 'Stopping this pest is a national security priority and we are linking arms across President Trump's cabinet to defend our borders and push back this threat,' said Agriculture Secretary Brooke L. Rollins.
Newsweek
18 minutes ago
- Newsweek
Shrimp Sold at Walmart May Be Radioactive: Warning Issued to Customers
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. The Food and Drug Administration (FDA) warned Americans that some shrimp products sold at Walmart may contain a radioactive substance known as Cesium-137. Newsweek reached out to Walmart for comment via email. Why It Matters The FDA warned that repeated low-dose exposure to Cesium-137 includes an "elevated risk of cancer" caused by DNA damage. "Internal exposure to Cs-137, through ingestion or inhalation, allows the radioactive material to be distributed in the soft tissues, especially muscle tissue, exposing these tissues to the beta particles and gamma radiation and increasing cancer risk," reads a fact sheet on the substance from the Centers for Disease Control and Prevention (CDC). What To Know The warning applies to "certain raw frozen shrimp products processed by PT. Bahari Makmur Sejati (doing business as BMS Foods), a company located in Indonesia, and sold at Walmart," the FDA said in a press release. Cesium-137 was discovered in shipping containers found at ports in Los Angeles, Houston, Miami and Savannah, Georgia, according to the press release. The FDA collected samples for analysis, which confirmed the presence of the substance in one sample of the shrimp product. All containers and products testing positive or alerting for Cesium-137 have been denied entry into the country, and no product that has tested positive for it has entered U.S. commerce. Still, consumers are urged to throw away any of the impacted lots of Great Value shrimp products, the FDA said. Distributors and retailers were also urged to dispose of the product. Anyone who suspects they may have been exposed should talk to their health care provider, the press release said. The level of Cesium-137 detected in the products would not be enough to "pose an acute hazard to consumers," but smaller, consistent exposure could increase the risk of cancer, the FDA said. The following products are affected by the warning. Great Value brand frozen raw shrimp with a lot code of 8005540-1 and a best by date of March 15, 2027 Great Value brand frozen raw shrimp with a lot code of 8005538 and a best by date of March 15, 2027 Great Value brand frozen raw shrimp with a lot code of 8005539-1 and a best by date of March 15, 2027 Stock photo of a shrimp platter displayed with sauce on a plate. Stock photo of a shrimp platter displayed with sauce on a plate. anyaivanova/iStock via Getty Images What People Are Saying The FDA wrote: "Although testing to date has not confirmed the presence of contamination in any product in commerce, the product appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with Cs-137 and may pose a safety concern. To date, FDA has learned that Walmart has received implicated raw frozen shrimp, imported after the date of first detection of Cs-137 by CBP, but from shipments that did not alert for Cs-137. FDA has recommended Walmart recall this product." The CDC, on Cs-137: "People are exposed to some Cs-137 every day, because amounts of Cs-137 are present in the environment from weapons testing in the 1950s and 1960s. However, Cs-137 is dangerous in the large, concentrated amounts found in radiation therapy units and industrial gauges. The sources in these devices are designed to remain sealed and keep people from being exposed. If these canisters are intentionally or accidentally opened, the Cs-137 inside could be dispersed." What Happens Next The FDA said it "will continue working with industry to trace all implicated products processed by PT. Bahari Makmur Sejati through the supply chain to gather as much information about them as possible and take action as appropriate." The advisory will be updated as more information becomes available, the FDA said.
