The S.E.C. alleged shortcomings in research said to support the drug, and its developer agreed to a $40 million settlement. Some experts wonder why clinical trials have not been stopped.
Category: Food and Drug Administration
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F.D.A. Approves a New Antipsychotic Drug
Available antipsychotic treatments work by blocking dopamine receptors. The new drug, Cobenfy, takes a different approach.
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Nasal Flu Vaccine Is Approved for At-Home Use
The F.D.A. authorized AstraZeneca’s treatment to be given outside a health care setting, although it will still need a prescription.
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Salmonella Outbreak Prompts Egg Recall by Wisconsin Farm
Officials said 65 people in nine states have been infected in the outbreak, which has been traced to an egg farm. No deaths have been reported.
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Mushroom-Laced Candy Recall Highlights F.D.A.’s Limited Safety Role
More than 150 people were sickened from products sold at smoke and vape shops, providing evidence of the lax regulation of new food items.
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Teenage E-Cigarette Use Continues to Decline
The percentage of middle and high school students reporting that they vaped tobacco products dropped to about a third of those students reporting use of e-cigarettes at a vaping peak in 2019, a new survey shows.
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He Regulated Medical Devices. She Represented Their Makers.
Ethics rules barred Dr. Jeffrey E. Shuren from working on matters involving clients of his wife’s law firm. But he did not always step aside.
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Hot Summer Threatens Efficacy of Mail-Order Medications
The temperatures inside delivery trucks can reach twice the recommended threshold, but federal rules on drug storage conditions do not apply to the booming world of mail-order delivery.
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F.D.A. Declines to Approve MDMA Therapy, Seeking More Study
The agency said there was insufficient data to allow the use of a treatment for PTSD that involves the drug known as Ecstasy, according to the company seeking approval.
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Veterans and Lawmakers Lobby for Approval of MDMA Therapy
The F.D.A. is poised to rule on the therapeutic use of the club drug Ecstasy, a potential watershed moment in the nascent field of psychedelic medicine.
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F.D.A. Approves Blood Test for Colon Cancer Detection
While not a perfect alternative to colonoscopies or fecal tests, experts hope the test could lead to more people getting screened for colorectal cancers.
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New Drug Approved for Early Alzheimer’s
The drug, Kisunla, made by Eli Lilly, is the latest in a new class of treatments that could modestly slow cognitive decline in initial stages of the disease but also carry safety risks.