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

The FDA has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility in Massachusetts.

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, 2025, follows an inspection conducted from June 12 to July 9, 2024, and outlines multiple manufacturing violations for pharmaceuticals.

Elshoma McCoy, 49, of 176 Waverly St., Framingham, is charged with illegal possession of a firearm; illegal possession of a large capacity feeding device; improper storage of a firearm; trafficking in cocaine; and possession of cocaine with the intent to distribute.

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. | The FDA has slapped a warning letter on Sanofi’s Genzyme facility in Framingham,

Good morning! Here are the five things you need to know in local business news to start your busy — and still very cold — Thursday, including James Beard awards, an FDA warning, Big Lots for sale, GE Vernova's success and giant pink men without pants.

A fast-casual restaurant that serves Korean and Mexican food has received approval to open on Route 9 in Framingham.

Framingham-based retail parent TJX Cos. has purchased two office parcels on Framingham’s Speen Street for $24.3 million.

Some Massachusetts health experts expressed concerns about Robert F. Kennedy Jr.'s potential appointment following his Senate hearing.

The best banks or credit unions for Massachusetts residents are the ones that operate in the state. We reviewed banks that do business in Massachusetts and found Synchrony, Rockland Trust Bank ...

Thomas Method said he entered the Capitol building but left within 10 minutes because he didn't know it was going to turn violent.

Biogen and Sage co-developed Zurzuvae, which was approved by the FDA for PPD in August 2023. Sage has experienced several setbacks since this approval. Zurzuvae did not win approval as a treatment ...