The FDA's assessment of the bread recall has designated it as a Class II risk, which means the product "may cause temporary or medically reversible adverse health consequences." However, the classification is also used "where the probability of serious adverse health consequences is remote."

FDA Commissioner Dr. Marty Makary joins Morning Joe to address the agency’s controversial decision to keep Juul e-cigarettes on the market, ongoing reviews of mifepristone, and the latest efforts on women's health and vaccine guidance.

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.

A Food and Drug Administration expert panel has reignited a debate over whether hormone therapy should be used to treat menopause. The 12-person panel encouraged the use of the

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational gene therapy trials for limb girdle muscular dystrophy following three patient deaths potentially linked to the company's treatments.

The U.S. Food and Drug Administration named ex-biotech exec George Tidmarsh as its chief drug regulator. FDA Commissioner Marty Makary called Tidmarsh an "accomplished physician-scientist and leader."

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

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

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

Replimune stock (ticker: REPL) cratered on Tuesday after the biotech said the U.S. Food and Drug Administration rejected an application seeking approval of its experimental skin cancer treatment.