FiercePharma9d
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 ...
dermatologyadvisor1d
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.
Becker's Hospital Review8d
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, ...
The Pharma Letter9d
FDA sends Sanofi warning letter over quality violations
The FDA issues a warning letter to Sanofi over manufacturing violations at its Massachusetts site, citing contamination and ...
STAT9d
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 ...
The Business Journals9d
Sanofi’s Framingham facility hit with FDA warning
Genzyme became a subsidiary of Sanofi and kept ... Related: Biggest Boston biotech news coming out of JPM 2025 Hologic gets FDA warning regarding implantable devices Related: Hologic gets FDA ...
ENDPOINTS NEWS9d
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 ...
Nature1mon
Genzyme backs Osiris, despite Prochymal flop
What's more, FDA and Health Canada have granted expanded ... know the differences between stem cell products,” he says. Genzyme and Osiris' partnership hinges heavily on Prochymal (Nat.
pharmaphorum1y
Sanofi gets FDA nod for long-acting haemophilia A drug
The FDA has cleared their once-weekly Factor VIII ... of the week,” according to Bill Sibold – head of the Sanofi Genzyme unit, which will be responsible for marketing the new drug – who ...
KAKE.com8d
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
THURSDAY, Jan. 23, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has warned ... for active pharmaceutical ingredients at their Genzyme manufacturing plant in Framingham ...