The U.S. Food and Drug Administration has warned the pharmaceutical company Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients at their Genzyme manufacturing plant in Framingham,

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,

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.

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

20% of bioreactor runs at the Genzyme facility failed due to contamination or quality issues over 2.5 years. FDA identified 84 overdue deviation investigations, some exceeding 180 days ...

The owner of six sandwich shop franchises located in different Central Massachusetts communities will be required to pay back wages to 12 employees after the U.S. Department of Labor filed a complaint against the stores for failing to pay the required overtime and failing to keep track of employee hours.

A Waltham biotech focused on cystic fibrosis and a Boston biotech led by serial founder Gary Glick are the first Massachusetts companies to set their sights on an IPO in 2025.

Massachusetts must pay the federal government $2.1 billion over the next 10 years to resolve a debt after the state under former GOP Gov. Charlie Baker's administration mistakenly used federal ...

Genzyme has fallen foul of the UK pharma industry code, for making misleading and disparaging claims about a competitor product. AstraZeneca has also been named in advertisements along with the ...

Genzyme continued to drive growth for Sanofi in the first quarter, helped along by the company’s vaccines unit, but diabetes drugs are still struggling. Net sales were €8,391 million, an ...

FRAMINGHAM — City officials announced the ... The MBTA Communities Act requires 177 communities in eastern Massachusetts to designate at least one zoning district that allows for multifamily ...

Reesa Morabito, Melissa McAfee and Mary Rapa join the SMILE Mass team as the non-profit organization completes it's biggest year to date. Continued growth results in need to expand staff.