“These observed higher adverse cardiac event rates in BVS patients were more likely when the device was placed in small heart vessels.” Read more
Dexilant is approved for the following indications in patients 12 years of age or older. Read more
The e-cigarette industry has had little to no oversight by government agencies until this past year. Read more
The dog food products were distributed to retail locations and sold online in 15 states. Read more
There is currently no requirement that food and cosmetic manufacturers report adverse events to the FDA. Read more
The FDA acknowledged in the letter that Aspen Hills had taken steps to address the listeria issue, including hiring a third-party laboratory. Read more
The case concerns three Takeda patents for Actos that were set to expire in January 2011, and two follow-up patents that were to expire in June 2016. Read more
Invokana squeaked through the FDA approval process by an 8-7 vote. Read more
We previously reported that the FDA had warned parents against using homeopathic teething products. Read more
Celgene had argued that the whistleblower could not identify a particular claim that was submitted as a result of its off-label promotion. Read more
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