The FDA has blocked the publication of COVID-19 and shingles vaccine safety studies, drawing concern from public health ...
In the latest update to COVID and vaccine-related discourse bubbling up at the FDA, agency officials have recently blocked ...
The FDA this month issued a warning letter to ImmunityBio regarding promotional statements about cancer drug Anktiva that the agency claims are “false or misleading.” The missive marks the first ...
Here’s everything you need to know.
FDA made clear that comments from ImmunityBio founder Dr. Patrick Soon-Shiong about prescription drugs in longform audio can trigger enforcement just like TV or digital ads. Regulators evaluated the ...
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...
The U.S. Food and Drug Administration sent a warning letter this month to Novo Nordisk, the maker of Ozempic and Wegovy, alleging the drugmaker failed to report potential side effects in patients who ...
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What you need to know about FDA drug safety alerts
The FDA’s safety communications, recalls, and boxed warnings protect patients from risks that may surface long after a drug is approved. These updates can change which medications are prescribed and ...
After Medline pulled off a massive $6.26 billion IPO late last year, the company now finds itself facing serious concerns being leveled by the FDA. The company is a mammoth medical device distributor ...
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