#FDA
#FDA

Medicine

The FDA is weighing whether to approve MDMA for PTSD. Here's what that could look like for patients.

FDA's proposed restrictions on MDMA for PTSD patients include monitoring safeguards and restricted administration at healthcare facilities. [ more ]

www.dailycamera.com

Medicine

Illegal ecstasy takes step toward becoming legal drug for PTSD

U.S. regulators may approve MDMA (ecstasy) for PTSD treatment, a first in over two decades. [ more ]

www.nytimes.com

Medicine

F.D.A.'s Review of MDMA Cites Health Risks and Study Flaws

The FDA raised concerns about the use of MDMA for PTSD treatment due to flaws in studies and potential health risks. [ more ]

Nature

OMG science

Randomized trials of cancer drugs are for yesterday

Pitting new treatments against old, ineffective agents is neither ethical nor economical. [ more ]

Hubspot

Marketing

Pharmaceutical Advertising: What It Is & Trends To Look Out For in 2024

Pharma ads are highly regulated, requiring disclosure of side effects alongside benefits. [ more ]

Ars Technica

Medicine

FDA's review of MDMA for PTSD highlights study bias and safety concerns

MDMA for PTSD therapy efficacy is under FDA review due to flawed trials and safety concerns, marking a potential shift in federal policy. [ more ]

Cbsnews

Medicine

The FDA is weighing whether to approve MDMA for PTSD. Here's what that could look like for patients.

FDA's proposed restrictions on MDMA for PTSD patients include monitoring safeguards and restricted administration at healthcare facilities. [ more ]

www.dailycamera.com

Medicine

Illegal ecstasy takes step toward becoming legal drug for PTSD

U.S. regulators may approve MDMA (ecstasy) for PTSD treatment, a first in over two decades. [ more ]

www.nytimes.com

Medicine

F.D.A.'s Review of MDMA Cites Health Risks and Study Flaws

The FDA raised concerns about the use of MDMA for PTSD treatment due to flaws in studies and potential health risks. [ more ]

Nature

OMG science

Randomized trials of cancer drugs are for yesterday

Pitting new treatments against old, ineffective agents is neither ethical nor economical. [ more ]

Hubspot

Marketing

Pharmaceutical Advertising: What It Is & Trends To Look Out For in 2024

Pharma ads are highly regulated, requiring disclosure of side effects alongside benefits. [ more ]

morefda

www.scientificamerican.com

Science

Asthma Drug Still Being Prescribed to Kids Despite Potential Mental Health Risks

Montelukast, a widely prescribed asthma and allergy drug, has been linked to psychiatric side effects such as hallucinations and suicidal thoughts, especially in children.

The FDA has issued a black box warning about these side effects, prompting researchers to investigate how montelukast affects the brain.

Montelukast and other leukotriene modifiers are intended to block chemicals that trigger asthma and allergy symptoms but should not cross the blood-brain barrier. [ more ]

time.com

Medicine

Drugs like Ozempic and Wegovy Show No Link to Suicide, FDA Says

The FDA has conducted a preliminary review of side effects from popular drugs used to treat diabetes and obesity and found no link with suicidal thoughts or actions.

The agency will continue to investigate reports regarding more than a dozen drugs, including Ozempic, Wegovy, and Mounjaro. [ more ]

Axios

Public health

FDA finds no immediate link between weight-loss drugs and suicidal thoughts

The FDA found no evidence linking obesity drugs to suicidal thoughts or actions in a preliminary review.

Demand for obesity drugs has surged despite insufficient data about their long-term effects and how they work in certain populations. [ more ]

Axios

Medicine

FDA finds no immediate link between weight-loss drugs and suicidal thoughts

The FDA found no evidence linking obesity drugs to suicidal thoughts or actions in a preliminary review.

Demand for obesity drugs has surged despite insufficient data about their long-term effects and how they work in certain populations. [ more ]

Axios

Public health

As hackers escalate health care attacks, growing concerns over medical devices

Medical devices in hospitals and patients' homes are potential targets for hackers due to vulnerabilities and outdated software.

Government watchdogs have called for improved coordination on the cybersecurity of medical devices. [ more ]

Axios

Information security

As hackers escalate health care attacks, growing concerns over medical devices

Medical devices in hospitals and patients' homes are potential targets for hackers due to vulnerabilities and outdated software.

Government watchdogs have called for improved coordination on the cybersecurity of medical devices. [ more ]

Cbsnews

Public health

Kratom faces scrutiny over health risks

Kratom is commonly marketed as a health wonder, but the FDA warns of "serious adverse effects."

It has even been blamed for several deaths.

Mark Strassmann reports.

Washington Post

Health

Did anything good happen in 2023? Actually, yes!

It's fair to say 2023 has been a difficult year in a lot of ways.

Bloomberglaw

Marketing

TikTokers Put Consumers at Risk as Drug Ads Go Unchecked by FDA

The FDA has not effectively regulated misleading drug claims on social media despite having the power to do so

Social media ads for pharmaceutical companies often lack warnings about side effects [ more ]

#CRISPR

time.com

Health

FDA Approves First CRISPR Treatment in U.S.

The U.S. FDA has approved the first gene therapy treatment based on CRISPR technology.

The treatment, called exa-cel, is approved for sickle cell disease and may also be approved for beta thalassemia. [ more ]

time.com

Health

FDA Approves First CRISPR Treatment in U.S.

The U.S. FDA has approved the first gene therapy treatment based on CRISPR technology.

The treatment, called exa-cel, is approved for sickle cell disease and may also be approved for beta thalassemia. [ more ]

time.com

Health

FDA Approves First CRISPR Treatment in U.S.

The U.S. FDA has approved the first gene therapy treatment based on CRISPR technology.

The treatment, called exa-cel, is approved for sickle cell disease and may also be approved for beta thalassemia. [ more ]

time.com

Health

FDA Approves First CRISPR Treatment in U.S.

The U.S. FDA has approved the first gene therapy treatment based on CRISPR technology.

The treatment, called exa-cel, is approved for sickle cell disease and may also be approved for beta thalassemia. [ more ]

moreCRISPR

time.com

Medicine

FDA Approves First CRISPR Treatment in U.S.

The U.S. FDA has approved the first gene therapy treatment based on CRISPR technology.

The treatment, called exa-cel, is approved for sickle cell disease and may also be approved for beta thalassemia. [ more ]

www.npr.org

Health

FDA approves first gene-editing treatments for human illness

The FDA has approved the first gene-editing treatments for sickle cell disease, marking a milestone in the field of gene-editing.

The treatments have the potential to provide more targeted and effective treatments for rare diseases with limited current options. [ more ]

www.npr.org

Science

FDA approves first gene-editing treatments for human illness

The FDA has approved the first gene-editing treatments for sickle cell disease, marking a milestone in the field of gene-editing.

The treatments have the potential to provide more targeted and effective treatments for rare diseases with limited current options. [ more ]

www.npr.org