FDA cites contamination concerns in warning to Sanofi MA plant
Jan 22, 2025 · The FDA has requested Sanofi to respond to it with corrective action plans within 15 days. When contacted, a Sanofi spokesperson told us: "Patient safety and the quality of our …
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
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. …
Warning Letters | FDA - U.S. Food and Drug Administration
Learn about the types of warning letters on FDA's website. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient …
Sanofi API plant hit with FDA warning letter detailing quality ...
Jan 21, 2025 · The FDA has slapped a warning letter on Sanofi’s Genzyme facility in Framingham, Massachusetts, after an inspection last summer uncovered issues around …
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
THURSDAY, Jan. 23, 2025 -- The U.S. Food and Drug Administration has warned the pharmaceutical company Sanofi about significant deviations from Current Good Manufacturing …
Sanofi warned by FDA over 'significant' problems at a key ... - STAT
Jan 21, 2025 · The Food and Drug Administration has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility in …
FDA approves Beyfortus™ (nirsevimab-alip) to protect infants ... - Sanofi
Jul 17, 2017 · The U.S. Food and Drug Administration (FDA) has approved Sanofi and AstraZeneca’s Beyfortus™ (nirsevimab-alip) for the prevention of respiratory syncytial virus …
Press Release: Update on FDA priority review of Dupixent for ... - Sanofi
May 31, 2005 · Sanofi and Regeneron are motivated to transform the treatment paradigm of COPD by examining the role different types of inflammation play in the disease progression …
Tolebrutinib designated Breakthrough Therapy by the FDA for non ...
Dec 13, 2024 · The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tolebrutinib for the treatment of adults with non-relapsing secondary progressive …
Press Release: FDA approves once-weekly ALTUVIIIO™, a new ... - Sanofi
Feb 23, 2021 · Paris and Stockholm – February 23, 2023 – The U.S. Food and Drug Administration (FDA) has approved ALTUVIIIO™ [Antihemophilic Factor (Recombinant), Fc …