The substantial presence of specialty pharmaceuticals companies in the CDER approval list ... may be that the FDA is using this requirement to gain more time in reviewing products,” suggests ...

In accepting the FDA’s motion, U.S. District Judge Mark Pittman put on hold a lawsuit filed by the Outsourcing Facilities ...

It’s important to look at the ingredients list of any supplement you ... to your doctor before starting any new supplement regimen. Are there any FDA approved supplements for perimenopause ...

Facing a lawsuit, the Food and Drug Administration has decided to reconsider its decision to take popular weight-loss and diabetes drugs off of the national shortage list, which will allow compounding ...

With an estimated 2 million people in the United States taking copycat vers | A compounding industry group has sued the FDA, ...

Imuldosa (ustekinumab-srlf) is the fifth ustekinumab biosimilar referencing Stelara to receive regulatory approval in the US.

Imuldosa (ustekinumab-srlf) is the fifth ustekinumab biosimilar referencing Stelara to receive regulatory approval in the US.

On October 2, 2024, the U.S. Food and Drug Administration (FDA) determined the shortage of the tirzepatide injection, a glucagon-like peptide ...

The US regulator has said that compounders can continue to trade in tirzepatide products while it undertakes a review to ...

In Teva Branded Pharm. Prods. R&D v. Amneal Pharms. of N.Y., LLC, the US District Court for the District of New Jersey ordered Teva to delist ...