A pair of Chinese manufacturers whose active pharmaceutical ingredients (API) were previously shipped to the U.S. | The FDA ...

The US Food and Drug Administration (FDA) has issued several warning letters to pharmaceutical manufacturers in India and ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its ...

Susan Krause of Rosemount alleges New Jersey-based Integra LifeSciences pressured her to lie to regulators. Integra says ...

An Alabama senator has introduced a bill to ban intoxicating hemp products, such as delta-8 THC, making Alabama the latest ...

Bard Peripheral Vascular, a subsidiary of Becton, Dickinson and Co., has reported 30 serious injuries and four deaths linked to the device due to a potential risk of helix fractures or breakages ...

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, ...

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 ...

Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration ...

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 U.S. drug ingredients plant tied to its longstanding subsidiary Genzyme.

NEW YORK, NY / ACCESS Newswire / February 5, 2025 / If you suffered a loss on your Applied Therapeutics, Inc. (NASDAQ:APLT) investment and want ...