The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.
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, ...
Sanofi (NASDAQ:SNY) has received EU regulatory approval for its drug Sarclisa for the treatment of newly diagnosed multiple myeloma patients. The drug was approved for use in combination with a ...
The FDA issues a warning letter to Sanofi over manufacturing violations at its Massachusetts site, citing contamination and ...
A new FDA warning letter for French pharmaceutical company Sanofi cited a handful of issues at its biologics factory in ...
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 ...
The warning letter follows an FDA inspection of Hologic’s Marlborough, Massachusetts, headquarters between July 30, 2024, and Sept. 24, 2024. The FDA raised concerns that Biozorb’s device design did ...