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, ...
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 ...
CBS News14d
How food brands and drugmakers are responding to FDA's ban of food dye Red 3
The FDA says that food companies will have until Jan. 15, 2027 to stop using the dye. Drugmakers will have an extra year, until January 2028, to comply with the change. Red 3, also known as ...
BioSpace16d
Izotropic Announces Team Leading Clinical Study Design and FDA Regulatory Submissions
New FDA Consultant is the former Director of the Division of Imaging ... C.R Bard, Smiths Medical, ACMI, Genzyme, Pfizer Hospital Products, and various start-ups. He is the former VP of Regulatory ...
UPI16d
New FDA proposal would put 'front-of-package' nutrition labels on food products
Jan. 14 (UPI) --The U.S. Food and Drug Administration hopes "front-of-package" labeling will better improve the American population's health, the FDA announced. "Food should be a vehicle for ...
Nature29d
2024 FDA approvals
The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new small molecules, biologics and oligonucleotide therapeutics last year. The class of 2024 was a little smaller than that ...
verywellhealth29d
The 12 Most Common Types of Drug Addictions
Substance abuse in the United States is one of the leading health conditions impacting millions of lives and due to many types of drug addictions. Since 2000, there have been 700,000 overdose deaths ...
stockhead1mon
ASX healthcare 2024 winners and losers, plus what’s next for 2025
Mesoblast (ASX:MSB) was the top performer for the year up 835% (as of December 30). On December 18 Mesoblast announced that the US Food and Drug Administration (FDA) had finally approved its therapy ...
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 ...
pharmaphorum12y
Sanofi’s Genzyme presents positive phase 3 data for MS drug
Genzyme are now moving towards refilling its FDA application for its other MS drug, Lemtrada. "We are on track to satisfy the questions of navigability from the FDA. We are also having ...