At least eight people in four states have fallen ill after eating Diamond Shruumz-brand Microdosing Chocolate Bars, including several who had seizures or lost consciousness and needed to be placed on ventilators. People also developed high blood pressure and abnormal heart rates. The Food and Drug Administration has warned people against consuming the bars, which…
An independent advisory panel of the Food and Drug Administration rejected the use of MDMA-assisted therapy for post-traumatic stress disorder on Tuesday, highlighting the unparalleled regulatory challenges of a novel therapy using an illegal drug commonly known as Ecstasy. Before the vote, members of the panel raised concerns about the designs of the two studies…
The Food and Drug Administration is weighing whether to approve the use of MDMA, also known as Ecstasy, for treatment of post-traumatic stress disorder. An independent advisory panel of experts will review studies on Tuesday and is expected to vote on whether the treatment would be effective and whether its benefits outweigh the risks. The…
The Food and Drug Administration on Friday raised concerns about the health effects of MDMA as a treatment for post-traumatic stress disorder, citing flaws in a company’s studies that could pose major obstacles to approval of a treatment anticipated to help people struggling with the condition. The agency said that bias had seeped into the…
A committee of experts that advises the Food and Drug Administration voted by large majorities on Thursday that a new blood test to screen people for colon and rectal cancers was safe and effective, and that its benefits outweighed its risks. But the group cautioned that the blood test had limitations and added that they…
The Food and Drug Administration on Thursday approved an innovative new treatment for patients with a form of lung cancer. It is to be used only by patients who have exhausted all other options to treat small cell lung cancer, and have a life expectancy of four to five months. The drug tarlatamab, or Imdelltra,…
The Food and Drug Administration on Wednesday approved the sale of an antibiotic for the treatment of urinary tract infections in women, giving U.S. health providers a powerful new tool to combat a common infection that is increasingly unresponsive to the existing suite of antimicrobial drugs. The drug, pivmecillinam, has been used in Europe for…
A troubled heart pump that has now been linked to 49 deaths and dozens of injuries worldwide will be allowed to remain in use, despite the Food and Drug Administration’s decision to issue an alert about the risk that it could puncture a wall of the heart. The tiny Impella pumps, about the width of…
Wegovy, the blockbuster weight loss drug, is now approved for a new use: reducing the risk of heart attacks, strokes and cardiovascular-related death in adults who have heart disease and are overweight or have obesity. The new indication, which the Food and Drug Administration announced on Friday, will pave the way for even more patients…
Nonfat or full-fat, flavored or plain, probiotic or natural — yogurt is already peppered with labels. But you may soon see a new claim on your container: This month, the Food and Drug Administration announced it will allow yogurt makers to say their products may prevent Type 2 diabetes. The F.D.A. said it has found…
