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US FDA declines full approval for Intercept's liver disease drug
Under the accelerated pathway, the FDA mandates additional trials that verify the drug's benefits. If the data from the ...
Detroit Free Press on MSN4h
Nearly 80,000 pounds of Costco butter recalled for missing 'Contains Milk statement': FDA
Nearly 80,000 pounds of Costco butter was recalled because its packaging was missing the "Contains Milk statement." ...
FiercePharma5h
FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains
Intercept on Tuesday revealed that it received a complete response letter (CRL) from the FDA, dashing the company’s hopes of ...
The FDA is urging these brands of ground cinnamon products to issue voluntary recalls
The products are part of the agency's ongoing public health alert concerning cinnamon with elevated lead levels ...
MM&M2h
FDA rule on TV drug ads: compliance boon or comprehension bust?
Set to become compulsory Nov. 20, the regulation isn't likely to make pharma ads easier for consumers to comprehend, but ...
These Cold & Flu Medicines Contain an Ingredient the FDA Plans to Ban
The FDA proposed a ban on phenylephrine, a common decongestant found in cold and cough medications. Here’s why and a list of ...
STAT19h
FDA commissioner suggests RFK Jr. and Trump might compromise an agency ‘at peak performance’
The agency’s ability to hire and retain skilled employees may be in jeopardy given Trump ally Robert F. Kennedy Jr.’s ...
The Pharma Letter28m
FDA slaps CRL on Ocaliva sNDA
Intercept Pharmaceuticals, now wholly owned subsidiary of Italy’s Alfasigma, today revealed that the US Food and Drug ...
FierceBiotech1h
J&J gets FDA thumbs-up to begin clinical trials for its Ottava surgical robot
Johnson & Johnson MedTech has received a go-ahead from the FDA to begin human clinical trials of its Ottava surgical robot, ...
Yahoo8h
FDA extends expiration date for at-home COVID-19 tests: What you need to know
For those families ready to throw them away after having the test for only one month, the US Food and Drug Administration ...
Local 12 WKRC Cincinnati6h
FDA recalls 80,000 pounds of Costco butter for not mentioning it contains milk
UNDATED (WKRC) - Nearly 80,000 pounds of butter were recalled from Costco stores after the FDA discovered the packaging did ...
MassDevice19h
Philips wins FDA clearance for new detector-based radiotherapy system
Philips announced that the FDA granted 510(k) clearance for its new detector-based spectral computed tomography (CT) ...