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

Shares of drugmaker Sarepta Therapeutics continued to fall Tuesday after the company said it would comply with a Food and ...

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

Dr. George Tidmarsh, a Stanford pediatrics adjunct professor and former pharmaceutical executive, is FDA Commissioner Marty Makary’s pick to be the nation’s top drug regulator.

This is the web edition of D.C. Diagnosis, STAT's twice-weekly newsletter about the politics and policy of health and ...

Analysts questioned whether the complete response letter Replimune received was evidence of changing approval standards at ...

Taking medication for an allergic reaction? You might face severely itchy skin as a side effect of Zyrtec or Xyzal, according ...

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

Mushrooms sold across two states have been recalled over fears they could be harboring listeria, a bug that "can cause ...

FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

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

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