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,
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,
Hosted on MSN8d
FDA lifts hold on Opella’s trial to support switch of Cialis to OTC drug
The US Food and Drug Administration (FDA) has removed the clinical hold on a trial of Cialis (tadalafil) by Sanofi's consumer healthcare business, Opella. Opella had launched the actual use trial (AUT) to support its planned switch of Cialis from a prescription to an over-the-counter (OTC) medicine.
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.
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 ...
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.
BioSpace1h
Sanofi Earnings Driven by Dupixent, New RSV Vaccine as Hunt for Deals Continues
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.
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),
BioSpace1d
Two Years Into Novavax Reset, CEO Jacobs Hunts for Silver Linings
After two years characterized by layoffs, pipeline reorganizations, FDA delays and clinical holds, Novavax CEO John Jacobs says the company is at a pivot point.