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 ...
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 ...
FDA staff raises eye damage concerns for GSK's blood cancer drug
The U.S. Food and Drug Administration's staff reviewers on Tuesday raised safety concerns that GSK's blood cancer drug ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Ars Technica8y
About a third of FDA-approved drugs go on to have major safety issues ...
The drugs that gained FDA approval right before the deadline for their review were more likely to have post-market safety issues. On the flip-side, drugs with the quickest approvals (under 200 ...
Los Angeles Times8y
The odds of a drug having a significant safety issue after winning FDA ...
New drugs are generally tested first in hundreds or even thousands of people for safety and effectiveness. “We know that safety concerns, new ones, are going to be identified once a drug is used ...