ABC News

The FDA rejected an application for the drug MDMA, in combination with therapy, as treatment for PTSD on Friday.

FDA rejects MDMA in combination with therapy as treatment for PTSD

The Hill

The Food and Drug Administration (FDA) on Friday denied approval of an MDMA-based treatment for post-traumatic stress disorder (PTSD), the manufacturer said, a major setback for the use of psychedelic drugs as medicine. Drug company Lykos Therapeutics said the FDA told them the treatment “could not be approved based on...

FDA denies approval for MDMA therapy for PTSD

The Independent

 Federal health regulators on Friday declined to approve the psychedelic drug MDMA as a therapy for PTSD, a major setback for groups seeking a breakthrough decision in favor of using mind-altering substances to treat serious mental health conditions.Drugmaker Lykos Therapeutics said the FDA notified the company that the drug “could not be approved based on data submitted to date,” and requested an additional late-stage study. Such studies generally takes several years and millions of dollars to conduct. The drugmaker said it plans to ask the agency to reconsider.Lykos and other psychedelic companies had hoped that MDMA would be approved...

FDA won't approve psychedelic MDMA for PTSD, calling for additional study

The company expects Xembify’s expanded use to be available in the U.S. by the end of September. The expanded label aims to minimize the burden of care for patients with primary immunodeficiencies. The FDA approved an expanded label for Xembify, a 20% subcutaneous immunoglobulin used to treat primary immunodeficiencies...

FDA approves Xembify for biweekly dosing, treatment-naïve patients

Reuters

(Reuters) -The U.S. FDA has declined to approve a therapy based on the mind-altering drug MDMA for patients with post-traumatic stress disorder, stating it could not be approved based on the data submitted, developer Lykos Therapeutics said on Friday.

US FDA declines to approve first MDMA-based PTSD treatment

The U.S. Food and Drug Administration has issued a new warning about a popular medication used for weight loss. The FDA says it has received reports of people overdosing on compounded semaglutide, giving themselves as much as 20 times more than the intended dose of the medication. The incidents, some...

Some people are overdosing on semaglutide, FDA warns

More people have been stuck ill from eating Diamond Shruumz brand edibles. The FDA has posted a list of hundreds of stores and online outlets selling the products. As of July 29, a total of 78 illnesses have been reported in 28 states. Sixty-five of the 78 people have reported seeking medical care, 40 have been hospitalized, and two deaths are under investigation.

FDA approves epinephrine nasal spray, a needle-free alternative to EpiPen

Federal drug safety regulators have received nearly 300,000 adverse event reports involving health problems with Ozempic, Wegovy, Mounjaro and similar drugs from the same class of medications, highlighting the growing concerns about side effects associated with the widely used diabetes and weight loss treatments. In a report published last week...

FDA Database Reveals High Number of Severe Adverse Events Involving Problem from Ozempic, Similar GLP1 Drugs

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The Lens

This year’s area of low oxygen in the Gulf of Mexico is larger than average, the National Oceanic and Atmospheric Administration (NOAA) announced on Thursday. The “dead zone” is approximately 6,705 square miles , as measured last week. Within NOAA’s 38 years of measuring the dead zone, this year’s assessment marks the 12th-largest area of low to no oxygen, which can kill fish and marine life.

Gulf ‘dead zone’ larger than average, larger than expected for 2024, scientists announce

NewsNinja

A lady is cautioning others about purchasing budget earrings from Amazon, Shein, and H&M, after she experienced keloid formations on her earlobes due to wearing them. On a TikTok post that has garnered more than 334,000 likes, Sailor Rozema (@sailor.rozema), a content creator, shares a warning with her community of "dangly earring girls": the inexpensive jewelry found in fast fashion can have negative impacts on your well-being.

‘I’ll never be wearing earrings for the rest of my life’: Customer warns against buying from Shein

TMS has been found to be effective for treating clinical depression and other conditions. Prior data and clinical experience suggest that TMS may be more effective than ongoing medication management. Recent work comparing medication and TMS finds that TMS is more effective than multiple medication changes. Transcranial magnetic stimulation (TMS,...

TMS Outperforms Medication in Study of Treatment-Resistant Depression

Crexont kept symptoms at bay for an extra 30 minutes a day when compared with other Parkinson’s drugs. Amneal Pharmaceuticals Inc. announced yesterday the FDA approval for Parkinson’s drug Crexont (carbidopa and levodopa) via a news release on their website. This novel medication, formerly known as IPX203, combines two common drugs into one capsule.

FDA Approval Granted for Novel Parkinson’s Treatment

The FDA cleared the SeCore CDx HLA A Sequencing System as a companion diagnostic for afamitresgene autoleucel in advanced synovial sarcoma. The FDA has granted 510(k) clearance to the SeCore™ CDx HLA A Sequencing System for use as a companion diagnostic for afamitresgene autoleucel (afami-cel; Tecelra) in select adult patients with unresectable or metastatic synovial sarcoma.1.

FDA Clears Companion Diagnostic for Afami-Cel in Pretreated Metastatic Synovial Sarcoma

Intranasal administration is a novel delivery method for the treatment of inflammatory human diseases. London-based Tiziana Life Sciences recently received fast track designation from the FDA for intranasal foralumab in the treatment of nonactive secondary progressive multiple sclerosis (SPMS). The company’s lead candidate is a fully human anti-CD3 monoclonal antibody currently in a phase 2a trial for the potential treatment of nonactive SPMS.

Intranasal Foralumab Receives Fast Track Designation for Nonactive Secondary Progressive MS

Denver, CO

Contributors represent independent, third-party users who have joined our contributor program and self-verified their accounts. They have also demonstrated their experience writing hard news for other outlets. Contributors are expected, like all users, to adhere to our Community Standards.

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David Heitz

More dangerous substances are entering the Denver drug supply, Harm Reduction Action Center warned in a newsletter this week. “The Iron Law of Prohibition posits that as law enforcement becomes more intense, the potency of prohibited substances increases,” HRAC Executive Director Lisa Raville wrote in the newsletter. That is exactly what is happening, she said.

Dangerous substances entering Denver drug supply

Summary: Diality received FDA 510(k) clearance for its Moda-flx Hemodialysis System, which aims to enhance kidney disease treatment with customizable features and improved usability. This system supports various dialysis treatments and is designed to reduce the burden of care for patients and providers in multiple care settings. Key Takeaways:. FDA...

Diality Receives FDA Clearance for Moda-flx Hemodialysis System

Healthline

Zepbound and Mounjaro have been on the Food and Drug Administration's shortage list for months. In response, manufacturer Eli Lilly spent billions ramping up production and now, according to the FDA, they are available again.

FDA Says Mounjaro, Zepbound Shortage Has Ended: What to Know

The Current GA

Since 2020, the condition known as long COVID-19 has become a widespread disability affecting the health and quality of life of millions of people across the globe and costing economies billions of dollars in reduced productivity of employees and an overall drop in the work force .

Expert: Long COVID puzzle pieces are falling into place – picture is unsettling

New Jersey State

Morristown Minute

A new initiative aims to provide housing for vulnerable Medicaid members, enhancing community wellness and support. MORRIS COUNTY, N.J. - In a significant move to tackle housing instability among Medicaid recipients, New Jersey's Human Services Commissioner Sarah Adelman, along with Community Affairs Commissioner Jacquelyn A. Suárez, today announced the availability of $95 million in funding for developers. This initiative, part of the Healthy Homes program, is designed to create affordable housing opportunities for NJ FamilyCare members who are either homeless, at risk of homelessness, or currently living in institutional settings.

$95 Million for Healthy Homes: Housing for Medicaid Members

NewsBreak

FDA gives thumbs down to MDMA for now, demanding further research

On Friday, drugmaker Lykos Therapeutics received word from the Food and Drug Administration that the agency has decided not to approve MDMA-assisted therapy for PTSD at...

FDA gives thumbs down to MDMA for now, demanding further research

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