STAT7d
Sanofi is warned by the FDA over ‘significant’ problems at a key manufacturing plant
The FDA has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility in Massachusetts.
Cancer Therapy Advisor1d
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
The FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice regulations for active pharmaceutical ingredients.
FiercePharma7d
Sanofi API plant hit with FDA warning letter detailing quality, consistency flubs
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,
Becker's Hospital Review6d
FDA warns Sanofi over manufacturing violations
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.
ENDPOINTS NEWS7d
Sanofi says no sup­ply in­ter­rup­tions af­ter land­ing FDA warn­ing let­ter for US site
A new FDA warning letter for French pharmaceutical company Sanofi cited a handful of issues at its biologics factory in Massachusetts.
Medical Xpress4d
FDA warns Sanofi of manufacturing irregularities at key facility
The U.S. Food and Drug Administration has warned the pharmaceutical company Sanofi about significant ... their Genzyme manufacturing plant in Framingham, Massachusetts. On Jan. 15, 2025, a warning ...
Why Mayor Charlie Sisitsky, in his State of the City, said Framingham is 'strong'
Framingham Mayor Charlie Sisitsky delivered his fourth State of the City address Monday evening at Nevins Hall.
The MetroWest Daily News5d
Framingham wins 'conditional approval' for MBTA Communities Act plan. What it means
Sisitsky submitted his plan to comply with the law late last month after city councilors voted to table discussing the issue until February.
The MetroWest Daily News4d
Framingham mayor has several reasons to run for reelection. Here are some of them
With another city election looming in November, Framingham Mayor Charlie Sisitsky said he wants to finish what he has started.
pharmaphorum1d
Teva, Sanofi score well with anti-TL1A drug in IBD test
Armed with positive data from a phase 2b trial, Teva and Sanofi have decided to push their anti-TL1A antibody duvakitug into a phase 3 programme in inflammatory bowel disease (IBD). The results of ...
pharmaphorum4d
Sanofi takes SK Bio-partnered pneumococcal shot into phase 3
Sanofi has moved ahead with plans to challenge Pfizer and MSD for a piece of the market for pneumococcal vaccines, taking a 21-valent shot licensed from SK Biosciences into phase 3 testing.
WBJournal1d
TJX expands Framingham presence by purchasing two office buildings for $24.3M
Framingham-based retail parent TJX Cos. has purchased two office parcels on Framingham’s Speen Street for $24.3 million.