The FDA classifies this recall as Class II, which the agency describes as a situation "in which use of or exposure to a ...

Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the ...

The regulatory body determined that PTC Therapeutics’ New Drug Application for vatiquinone did not provide sufficient ...

The FDA's controversial rejection of a skin cancer therapy from Replimune Group has prompted Krystal Biotech to shut down of ...

The FDA says it will use artificial intelligence to expedite the approval of new drugs and devices. Investigators with the ...

The U.S. Food and Drug Administration has approved Tonmya (cyclobenzaprine hydrochloride) sublingual tablets for the ...

The FDA is warning the public not to eat, sell or serve certain Great Value raw frozen shrimp sold at Walmart due to possible ...

The warning is for some Great Value raw frozen shrimp because it may be contaminated with Cesium-137, a radioactive isotope.

Some packages of Great Value frozen shrimp sold at Walmart are at risk for potential for Cesium-137 contamination, the FDA ...

Artrya is celebrating the US FDA's approval of its second device for detecting and measuring dangerous coronary plaque. ...

John Konstantopoulos, Co-Founder and CEO of Artrya, said: "We are thrilled to have received FDA clearance of our Salix® Coronary Plaque module, which opens up a much greater revenue opportunity for us ...

They found that a drug called N-acetylcysteine, or NAC, can help reduce pain in patients who have had surgery—especially spinal surgery. The best part? NAC is already approved by the U.S. Food and ...