AT Topical products. Drug products that the FDA does not at this time consider to be therapeutically equivalent to other pharmaceutically equivalent products. B* Drug products that require further ...

The FDA is proposing many popular over-the-counter cold and allergy medications be removed from store shelves. The agency says a common ingredient they share, phenylephrine, doesn’t actually relieve ...

An FDA-approved biosimilar is a biological product which demonstrates that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of ...

It’s been more than three years since DBV Technologies’ peanuty allergy therapy was rejected for FDA approval, but the company thinks it now has a clear route to market with its patch product ...

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and ...

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and ...

And, they also take several weeks to give kids good disease protection. FDA charts suggest Moderna's vaccine kicks in at around 40 days after the first of two shots, while Pfizer's takes between ...