Yahoo13d
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
The U.S. Food and Drug Administration has warned the pharmaceutical company Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients at their ...
C&EN14d
50 new drugs received FDA approval in 2024
C&EN’s tabulation follows approvals from the FDA’s Center for Drug Evaluation and Research; therefore, it does not include blood products, gene therapies, vaccines, and other therapies that ...
Sanofi’s Framingham facility hit with FDA warning
French pharmaceutical giant Sanofi has received a warning letter from the U.S. Food and Drug Administration following an inspection at its drug manufacturing facility in Framingham.
Benzinga.com15d
Sanofi Genzyme Facility Draws FDA Criticism Over Alleged Quality Lapses
20% of bioreactor runs at the Genzyme facility failed due to contamination or quality issues over 2.5 years. FDA identified 84 overdue deviation investigations, some exceeding 180 days ...
FiercePharma16d
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. drug ingredients plant tied to its longstanding subsidiary Genzyme.
CBS News21d
How food brands and drugmakers are responding to FDA's ban of food dye Red 3
Companies say they are working to update their products to comply with the Food and Drug Administration's decision Wednesday to ban the artificial food dye Red 3, after the agency said it was ...
Forbes21d
FDA’s Red Dye No. 3 Ban, Explained—What It Means For Food And Trust
Red Dye No. 3, or erythrosine, is a synthetic red food dye once popular in candies and cakes. The ... [+] FDA bans Red Dye No. 3 under the Delaney Clause, citing cancer risks observed in lab ...
Associated Press21d
FDA bans red dye No. 3 from foods
Food and Drug Administration officials granted a 2022 petition filed by two dozen food safety and health advocates, who urged the agency to revoke authorization for the substance that gives some ...
Al Jazeera English21d
What is Red Dye 3 and why has the US FDA banned it in food and drinks?
On Wednesday, the Food and Drug Administration (FDA) proscribed the dye based on a 2022 petition by consumer advocacy groups against its use, which had already been banned in cosmetics 35 years ago.
ScienceAlert21d
FDA Finally Outlaws Red Food Dye Banned Around The World
Outgoing US President Joe Biden's administration on Wednesday announced a ban on Red Dye No 3, a controversial food and drug coloring long known to cause cancer in animals. Decades after scientific ...
Time22d
FDA Bans Red Dye No. 3 From Foods
Food and Drug Administration officials granted a 2022 petition filed by two dozen food safety and health advocates, who urged the agency to revoke authorization for the substance that gives some ...