STAT8d
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.
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 U.S. | The FDA has slapped a warning letter on Sanofi’s Genzyme facility in Framingham,
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.
Sanofi says FDA lifted clinical hold on trial for Cialis OTC switch
Sanofi’s (NASDAQ:SNY) consumer healthcare unit Opella announced Tuesday that the U.S. FDA has lifted a clinical hold on a trial designed to test an over-the-counter version of its erectile dysfunction (ED) drug,
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 Massachusetts.
The Pharma Letter8d
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 inadequate quality controls. The agency demands a comprehensive review, warning of potential regulatory actions.
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, 2025, follows an inspection conducted from June 12 to July 9, 2024, and outlines multiple manufacturing violations for pharmaceuticals.
STAT8d
Pharmalittle: We’re reading about a cancer therapy’s gold rush, FDA warning Sanofi, and more news
A Belgian court dismissed a lawsuit against EU chief Ursula von der Leyen centered on text messages she exchanged with Pfizer's CEO during negotiations for Covid shots.
US FDA approves Novo Nordisk's Ozempic to cut risk of diabetic kidney disease progression
The U.S. FDA has approved Novo Nordisk's Ozempic for reducing the risk of kidney failure and disease progression, as well as death due to heart problems in diabetes patients with chronic kidney disease (CKD),
Benzinga.com8d
Sanofi Genzyme Facility Draws FDA Criticism Over Alleged Quality Lapses
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 ...
FiercePharma9d
Sanofi's consumer health arm Opella secures FDA green light to pursue OTC Cialis study
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,
Medical Xpress6d
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. According to the ...