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

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

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

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

Replimune stock (ticker: REPL) cratered on Tuesday after the biotech said the U.S. Food and Drug Administration rejected an ...

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

Sarepta Therapeutics reversed course and agreed to halt all shipments of Elevidys, its gene therapy for Duchenne muscular ...

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s ...

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

But one thing we’re confident about is that nobody wants to use a deodorant that has been recalled, which is why we are ...

The U.S. Food and Drug Administration said on Monday it has appointed George Tidmarsh, a seasoned biotech executive and ...