FDA

Close to the White House in Lafayette Park, 17 pairs of Army boots form a solemn row. These boots represent a tragic statistic from the U.S. Department of Veterans Affairs: every day an average of at least 17 military veterans die by suicide. Advocacy Groups Urge FDA To Approve Psychedelic Therapy...

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...

Congressional leaders and veterans’ advocates converged at the U.S. Capitol to push for MDMA-assisted therapy as a potential breakthrough in PTSD treatment for military veterans. The event, marked by the solemn hanging of 150,000 military dog tags symbolizing lives lost to suicide since 9/11...

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"Unfortunately, the Committee completely lost sight of the big picture," said retired Lieutenant General of the US Marine Corps, Martin R. Steele. He was commenting on this week's recommendation by a committee of advisors to the U.S. Food and Drug Administration against the approval of MDMA-...

Thursday, the FDA selected Moderna Inc’s (NASDAQ:MRNA) mRNA-3705 for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. mRNA-3705 is an investigational therapeutic for methylmalonic acidemia (MMA) due to methylmalonic-CoA mutase (MUT) deficiency....

A committee of advisors to the U.S. Food and Drug Administration (FDA) dealt a blow to the burgeoning field of psychedelic medicine by recommending against the approval of MDMA-assisted therapy as a treatment for PTSD. MDMA, also known as ecstasy, has been studied for over a decade as a potential...

MDMA, the drug commonly known as ecstasy and declared illegal by the DEA in 1985, is nearing a landmark moment in its journey toward becoming a legal and approved treatment for PTSD. Lykos Therapeutics Inc., a company that emerged from the nonprofit Multidisciplinary Association for Psychedelic...

"Tremendous Excitement" Around Psychedelic Medicine, Says Top Federal Drug Official There is "tremendous excitement" about the therapeutic potential of psychedelics, says National Institute on Drug Abuse (NIDA) Director Nora Volkow. However, this top federal drug official emphasized that while...

The Federal Trade Commission (FTC) is intensifying its efforts to challenge numerous pharmaceutical patent listings, aiming to facilitate the availability of more affordable alternatives to brand-name drugs, including blockbusters like Novo Nordisk A/S’s (NYSE:NVO) Ozempic...

New Jersey Activists Defy Law And Plant A Cannabis Garden On The State House Lawn, Cops Show Up New Jersey activists staged a protest on the State House lawn by planting a cannabis garden without a permit, later sparking a confrontation with the police, according to Heady NJ. Despite the state...

In a House Oversight and Accountability Committee hearing Thursday, the commissioner of the Food and Drug Administration (FDA), Robert Califf faced a barrage of questions spanning various critical issues, from lead contamination in baby food to the regulation of hemp and cannabis-derived products...

The lightly regulated Delta-8 THC market was in the spotlight again on Wednesday as the U.S. Hemp Authority (USHA), a private effort, announced the industry's initiative to provide high standards, best practices and self-regulation. Due to specific wording in the 2018 Farm Bill, Delta-8 THC is...

The FDA granted accelerated approval on Thursday to Madrigal Pharmaceuticals Inc.’s (NASDAQ:MDGL) Rezdiffra (resmetirom) noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis) to be used along with diet and exercise.  Continued...

In the hallowed chambers of the Senate Finance Committee on Thursday, a testy exchange took place between Sen. John Cornyn (R-Texas) and Health and Human Services (HHS) Secretary Xavier Becerra. The bone of contention was the proposed rescheduling of marijuana under federal law. Cornyn grilled...