Tag Archives: FDA

The CRL goes on to suggest that Lykos conduct a new clinical trial in order to address these issues, which it says should focus on: Demonstrating durability of effect Minimising potential for bias Adequately characterising the safety of MDMA The agency provides more specific guidance for each of those broad areas of focus. It also recommended that Lykos “consider an …

FDA questions whether people should get multiple respiratory vaccines together  The Washington Post Source link

When my alarm sounds at 6:30, I roll my 32-week pregnant body onto its side and use my arms to push myself up to a sitting position, as the experts recommend, so that I don’t overly strain my core muscles. I plod down the stairs, gripping the rail to lighten my steps so as not to wake my two toddlers. …

The FDA expanded its shrimp warning to include Kroger Mercado and AquaStar cocktail shrimp tied to an Indonesian supplier. No U.S. retail samples have tested positive for Cesium-137, and no illnesses have been reported. A full import alert is in place while the investigation continues. We’ve already flagged the FDA’s warning about frozen shrimp with potential radioactive contamination. Now that …

A top official at the Food and Drug Administration (FDA) demanded the removal of YouTube videos of himself that were published by a physician and writer who has been critical of medical misinformation and public health officials in the Trump administration, according to a YouTube notice that was seen by the Guardian. Jonathan Howard, a neurologist and psychiatrist in New …

WASHINGTON — The Food and Drug Administration on Wednesday approved updated Covid boosters, but removed emergency use authorizations for the vaccines, in a set of moves that could make the shots more difficult to obtain for children under 5, in particular. The moves were announced by Robert F. Kennedy Jr., the secretary of Health and Human Services, in a post …

FDA limits approval for new coronavirus vaccines to high risk people  The Washington Post F.D.A. Approves Covid Shots With New Restrictions  The New York Times RFK Jr. limits who is eligible for COVID shots  Axios The latest COVID vaccines come with new FDA limits  NPR Pfizer and BioNTech’s COMIRNATY® Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 …

WASHINGTON (AP) — U.S. regulators approved updated COVID-19 shots Wednesday but limited their use for many Americans — and removed one of the two vaccines available for young children. The new shots from Pfizer, Moderna and Novavax are approved for all seniors. But the Food and Drug Administration narrowed their use for younger adults and children to those with at …

A novel implant has shown it can slow vision loss in macular telangiectasia type 2, offering the first approved treatment for this rare disorder. Credit: Stock Phase 3 clinical trial results from Scripps Research and its collaborators supported FDA approval of ENCELTO, the first cell-based treatment for the neurodegenerative retinal disease known as MacTel. For individuals with macular telangiectasia type …

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hey, good morning. Today, we see CBER suspend the license for a chikungunya vaccine, look at a push to recall a safety and efficacy study for the antidepressant Paxil, and more. FDA pulls license for chikungunya vaccine The Food and …