Pfizer’s PFE 2024 revenue reached $63.6 billion, near the high end of its $61 billion-$64 billion guidance range. Management ...
The FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice regulations for active pharmaceutical ingredients.
Novo Nordisk’s NVO amycretin, which targets GLP-1 and amylin in one molecule, generated 24% placebo-adjusted weight loss in a ...
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 ...
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, ...
Sanofi (NASDAQ:SNY) has received EU regulatory approval for its drug Sarclisa for the treatment of newly diagnosed multiple myeloma patients. The drug was approved for use in combination with a ...
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 ...
Genzyme became a subsidiary of Sanofi and kept ... Biggest Boston biotech news coming out of JPM 2025 Hologic gets FDA warning regarding implantable devices Hologic gets FDA warning regarding ...
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.
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 ...
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 ...