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

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,

Sanofi SNY and Roche RHHBY announced their fourth-quarter and full-year 2024 results. Novo Nordisk’s NVO novel obesity medicine, amycretin, showed superior weight loss in a study. Merck MRK announced mixed data from a phase III study on a combination regimen of its blockbuster PD-L1 inhibitor,

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

A new FDA warning letter for French pharmaceutical company Sanofi cited a handful of issues at its biologics factory in Massachusetts.

The FDA issues a warning letter to Sanofi over manufacturing violations at its Massachusetts site, citing contamination and inadequate quality controls. The agency demands a comprehensive review, warning of potential regulatory actions.

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 also found Genzyme’s proposed corrective and preventive actions (CAPAs) insufficient. Sanofi must respond within 15 working days, outlining its corrective measures and provide the FDA ...

Earnings Call Transcript January 30, 2025 Sanofi misses on earnings expectations. Reported EPS is $0.7 EPS, expectations were $0.71. Thomas Larsen: Welcome to the Q4 and Full Year 2024 Conference Call for Investors and Analysts.

After hitting a regulatory roadblock in 2022, Sanofi’s consumer healthcare business Opella has secured the FDA’s blessing to move forward with its ambition to convert its erectile dysfunction med C | The agency previously placed a hold on the company's prescription-to-OTC study for erectile dysfunction med Cialis,

Sanofi’s jump in earnings comes with an increased emphasis on R&D and vaccines, plus an eye cast toward M&A to shore up its pipeline.

On Jan. 15, 2025, a warning letter was sent to Sanofi stating that FDA inspectors found irregularities with the facility's bioreactor, the vessel used to grow organisms and cells. According to the ...