News

Sarepta drops as report suggests FDA needs new trials for Elevidys
Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...
FDA flags safety concerns related to GSK’s blood cancer drug ahead of AdCom meeting
In briefing documents released ahead of an Advisory Committee meeting this week, FDA staffers cited safety risks related to a ...
FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
STAT7h
Safety of fluoride supplements, and freedom of choice, debated at FDA meeting
But it’s unclear if the evidence provided to support continued use of fluoridated supplements will matter. The FDA said in ...
Que.com on MSN40m
AI in FDA Drug Approvals Sparks Controversy Over Fabricated Studies
In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...
The New York Sun54m
EU Finds No Major Health Concerns With RFK Jr.’s Public Enemy No. 1 — Fluoride
The review notes that the current legal limit for drinking water in the bloc is 1.5 milligrams of fluoride per liter, which ...
CBS News8y
Drug safety issues often arise after FDA approval, new study finds
FDA panel rejects drug that could combat rare terminal illness 02:40 "Some people might think it's alarming that one in three drugs are having a safety problem after approval.If you believe this ...
Yale Environment 3608y
New safety concerns identified for 1 in 3 FDA-approved drugs
Nearly one out of every three drugs approved by the Food and Drug Administration (FDA) have a new safety issue detected in the years after approval, says a Yale-led study.While most of the safety ...
FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies
Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...
Law3y
FDA Addresses Safety Concerns of Cannabis-Derived Products - Law.com
By addressing safety, labeling, misleading claims, and adulteration concerns, DAP enables the FDA to track, authorize and regulate the sale of cannabis-derived products and accelerates CDPs entry ...
Becker's Hospital Review5y
Rapid FDA drug approvals raise patient safety concerns
The FDA has been approving new drugs so quickly that some patient safety advocates are voicing concerns, according to Bloomberg. The FDA has 10 months to approve or deny a drugmakers ...
STAT1y
FDA has safety concerns on CRISPR-based sickle cell therapy - STAT
T he Food and Drug Administration said on Friday that it has some safety concerns about an experimental CRISPR-based treatment for sickle cell disease, citing the methods used by its makers to ...