Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 ...

The FDA has designed five different types of labels, each presenting the same information but with different specifications based on the size of the packaging.

[31,32] Among our sample of patients with low literacy skills ... could potentially lead to hazardous administration of the drug and an adverse reaction. This scenario was most notable on the ...

Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a ...

Hologic received a warning letter in December from the Food and Drug Administration related to safety concerns with the company’s Biozorb implantable radiographic markers. The FDA found that ...

The FDA has said it cannot approve tabelecleucel to treat patients 2 years of age and older who have EBV-positive PTLD and have received at least 1 prior therapy.

After a series of strongly worded letters—one of which was addressed directly to Commissioner Robert Califf—the FDA has ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...

Food companies criticize the science supporting front-of-package labeling, delay public consultation periods, push for their ...

To serve as a reminder of her insightful warning, we only have six years left! Are her words hyperbole, or are they supported by facts? Do you realize that carbon dioxide is not solely a pollutant?

Hologic stopped manufacturing the device after reports of serious adverse events in patients who had the markers implanted in ...

The U.S. Food and Drug Administration (FDA) has issued an update on a nationwide mushroom recall, announcing a Class I classification—the body's highest risk warning—on January 14. A recall ...