Sarepta Therapeutics is pausing shipments of its gene therapy for muscular dystrophy following several patient deaths that ...

The FDA's assessment of the bread recall has designated it as a Class II risk, which means the product "may cause temporary ...

A Food and Drug Administration expert panel has reignited a debate over whether hormone therapy should be used to treat ...

The Food and Drug Administration named a longtime pharmaceutical executive to run the agency’s drug program. Dr.

The U.S. Food and Drug Administration named ex-biotech exec George Tidmarsh as its chief drug regulator. FDA Commissioner ...

Stanford's George Tidmarsh has authored 143 scientific papers and patents, as well as played a central role in developing ...

Prefilled syringe eliminates the need to reconstitute separate vials prior to administration and simplifies the vaccine ...

The recall was for Rich Ice Cream Company, which is located in West Palm Beach, Florida, with the FDA saying it was for ...

The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...

FDA Commissioner Dr. Marty Makary joins Morning Joe to address the agency’s controversial decision to keep Juul e-cigarettes ...

(The Center Square) – Doctors on Monday urged the U.S. Food and Drug Administration to issue warnings to pregnant women ...

Taking medication for an allergic reaction? You might face severely itchy skin as a side effect of Zyrtec or Xyzal, according to a recent FDA warning for long-term users. Here's what you need to know.