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, ...

The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.

Federal regulators have warned a Waco, Texas, company that its human amniotic products are “unlicensed” and “unapproved,” and ...

Good morning! Here are the five things you need to know in local business news to start your busy — and still very cold — ...

The FDA issued a warning letter to Sanofi regarding significant manufacturing violations at its Genzyme Corporation Facility in Framingham, Mass. The letter, dated Dec. 16, 2024, and amended Jan. 15, ...

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 ...

Companies say they are working to update their products to comply with the Food and Drug Administration's decision Wednesday to ban the artificial food dye Red 3, after the agency said it was ...

A recall of a Pinsarella Roman Pizza product from Pinsarella Food has been classified as a Class I recall by the U.S. Food and Drug Administration (FDA) due to undeclared wheat and soy.

Barclays has sounded the alarm over a letter going out to customers, after a complaint from an individual regarding a change to their account. The customer reached out to the bank on social media ...

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 ...

highlighting its commercial advantage and setting a milestone for Sanofi. This achievement further underlines the drug’s efficacy across multiple indications, including atopic dermatitis (AD), in ...