News

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 ...
Houston-based Empower Pharmacy's drugs raised red flags for FDA and other states, but not Texas
Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.
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 ...
Fierce Pharma7d
FDA advisors spurn GSK's Blenrep comeback dreams on safety, trial concerns
On a quest to bring its multiple myeloma antibody-drug conjugate Blenrep back to the U.S. | Members of the FDA's Oncologic ...
STAT18h
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 ...
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 ...
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 ...
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 ...
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 ...