As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...
Federal regulators have warned a Waco, Texas, company that its human amniotic products are “unlicensed” and “unapproved,” and ...
The crisis is long over, but if you were a young family with babies three years ago, scary memories of escalating health worries and retail stores bereft of infant formulas remain.
As part of its enforcement activities, the Food and Drug Administration (FDA) sends warning letters to entities under its ...
On Jan. 15, 2025, a warning letter was sent to Sanofi stating that FDA inspectors found irregularities with the facility's ...
NEW YORK, NY / ACCESS Newswire / February 5, 2025 / If you suffered a loss on your Applied Therapeutics, Inc. (NASDAQ:APLT) investment and want ...
The volume of U.S. FDA warning letters to device makers oscillated significantly in recent years, but the agency posted a handful of these letters to kick off the new year. Five letters were posted ...
The FDA issued a warning letter to ProRx, a compounding facility in Exton, Penn., after an inspection raised serious concerns regarding the safety and compliance of its drug products. The facility, ...
Susan Krause of Rosemount alleges New Jersey-based Integra LifeSciences pressured her to lie to regulators. Integra says ...
Reports of anaphylaxis associated with the use of glatiramer acetate have prompted the Food and Drug Administration (FDA) to add a Boxed Warning to the prescribing information.
The FDA has advised health care professionals and patients with multiple sclerosis that treatment with glatiramer acetate is ...
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