Food and Drug Administration

In response to an E. coli outbreak associated with fresh onions, leading U.S. fast-food chains including McDonald’s Corp (NYSE:MCD), Restaurant Brands International (NYSE:QSR), and Yum Brands Inc. (NYSE:YUM) have decided to remove the vegetable from their menus. The outbreak has reportedly...

The Department of Veterans Affairs (VA) is signaling potential support for another pivotal Phase III clinical trial of psychedelic therapy to treat post-traumatic stress disorder (PTSD). As Politico reported, Dr. Shereef Elnahal, the undersecretary for health at the VA, revealed that the agency is...

Novo Nordisk (NYSE:NVO) has appealed to the U.S. Food and Drug Administration (FDA) to halt the production of compounded versions of its drugs Wegovy and Ozempic by compounding pharmacies. These cheaper alternatives have been under scrutiny due to potential safety risks and lack of FDA approval....

Antivaccine advocate and former independent presidential candidate, Robert F. Kennedy Jr., stated that he might be appointed by former President Donald Trump to select leaders for key public health agencies, should the former president win a second term. What Happened: Kennedy Jr. disclosed this...

The U.S. Food and Drug Administration (FDA) has issued a complete response letter for MDMA-assisted psychotherapy (MDMA-AT) for treating post-traumatic stress disorder (PTSD) in which it calls for an additional phase 3 trial to further evaluate its safety and efficacy. As Psychiatric Times...

The Multidisciplinary Association for Psychedelic Studies (MAPS) is pivoting its focus to state-level initiatives following the U.S. Food and Drug Administration's (FDA) recent denial of MDMA-assisted therapy. As recently reported by Double Blind, MAPS gathered a panel of experts to discuss what...

Moxy, known formally as 5-MeO-MIPT, is a powerful synthetic psychedelic that has gained momentum in recent years. Initially synthesized in the 1980s, the compound remained relatively obscure until the early 2000s, when interest in psychedelics grew, particularly among those exploring their...

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) has received a setback as the Food and Drug Administration has declined its application for a blood cancer treatment. What Happened: The FDA rejected Regeneron’s application for linvoseltamab, a treatment for a form of blood cancer, the company...

In a significant development in the field of psychedelic medicine, the journal Psychopharmacology has retracted three research papers on MDMA-assisted therapy due to what it described as unethical conduct at one of the study sites. As New York Times reported, the retraction has cast a shadow over...

The U.S. Food and Drug Administration (FDA) is on the verge of making a historic decision regarding the approval of Lykos Therapeutics MDMA-assisted therapy as a mainstream medical treatment for post-traumatic stress disorder (PTSD). The decision, expected by August 11, could mark a turning point...

In another bipartisan effort, U.S. Senators Michael Bennet (D-Colo.), Thom Tillis (R-N.C.), Kyrsten Sinema (I-Ariz.), and Rand Paul (R-Ky.), along with 15 colleagues called on the U.S. Food and Drug Administration (FDA) to base its upcoming decision on MDMA-Assisted Therapy for Post-Traumatic...

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have intensified their oversight of the cannabis industry, issuing another round of warning letters to companies on Tuesday. The businesses are accused of selling products infused with hemp-derived cannabinoids, such as...

The credibility of the clinical trial results for an experimental Alzheimer’s drug has been called into question following a critical inspection report by the Food and Drug Administration (FDA). What Happened: The FDA report, which was released under the Freedom of Information Act,...

FDA and Reagan-Udall Foundation are hosting a virtual public meeting on psychedelic research titled Advancing Psychedelic Clinical Study Design, which aims to explore empirical approaches to address issues in drug development. The U.S. Food and Drug Administration (FDA) together with the Reagan-...

As the cannabis industry continues to blossom, it becomes increasingly important to spotlight those at the forefront of the green revolution. In this evolving landscape, visionaries are emerging, shaping the industry, societal perceptions and legal frameworks. Here are the stories and...