Attorneys said many questions remain about the regulation of laboratory developed tests after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

A Texas court has struck down the FDA’s Final Rule to regulate LDTs in the same way as medical devices. But is that the end of the story?

The FDA said cetirizine and levocetirizine are the allergy medicines that could cause the itching side effect. They are sold under the brand names Zyrtec and Xyzal, respectively.

This decision, which asserts that the FDA does not have responsibility for the authorization and oversight of LDTs, removes established guardrails for diagnostic safety and accuracy that protect ...

The U.S. Food and Drug Administration has issued a warning about a rare but severe reaction that can happen to people who stop taking oral allergy medicines like Zyrtec or Xyzal.

Two antihistamines, including Zyrtec, are under warning by the FDA after people reported “severe itching” after ceasing long-term use of the drugs—what to know.

The FDA, under Health Secretary Robert F. Kennedy Jr., has taken another step to question the safety of Covid-19 vaccines.

The FDA warns that longtime users of popular allergy medications may experience "severe itching" after stopping use.

The US Food and Drug Administration has issued a warning about products containing tianeptine, often called “gas station heroin” because of its availability at gas stations.

The FDA is telling Pfizer and Moderna to expand warning labels about the risk of a rare heart condition after Covid-19 vaccination.

The FDA has not published more than a dozen letters that flagged hazards at food companies, including potential contamination, two sources said.