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 ...
There are new concerns that phenylephrine, an ingredient in common over-the-counter cold and allergy medicines is ineffective. The FDA said the ingredient is safe but many popular medicines are ...
The investigation is in its early stages, and 33 patients have been discovered. The Food and Drug Administration has not released any patient information, such as where the patients live or their ...
At a public forum last week, Peter Marks, the top vaccine regulator for the Food and Drug Administration, said the way to counter the movement is by being transparent. “We have to be steadfast ...
The Food and Drug Administration on Thursday proposed ending the use of a common ingredient found in many popular over-the-counter cold and allergy medications. The agency said an extensive ...
The Food and Drug Administration has announced a recall for thousands of bottles of the antidepressant duloxetine, sold under brand names like Cymbalta, due to the presence of a chemical that can ...
The FDA is proposing many popular over-the-counter cold and allergy medications be removed from store shelves. The agency says a common ingredient they share, oral phenylephrine, doesn’t ...
The FDA declined to comment. Aaron Siri, a lawyer for Public Health and Medical Professionals for Transparency, in a statement on Friday said the fight for records was not over. “Despite years ...
SILVER SPRING, Md., Nov. 7, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration announced it is proposing to remove oral phenylephrine as an active ingredient that can be used in ...
Iterum Therapeutics (ITRM) plc announced that the U.S. Food and Drug Administration has approved Iterum’s new drug application for Orlynvah for the treatment of uncomplicated urinary tract ...
Autolus Therapeutics (AUTL) announces the U.S. FDA has granted marketing approval for Aucatzyl for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic ...