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December 13, 2023
Sanofi has issued a statement expressing its disappointment with FTC’s decision to block an exclusive licensing agreement with Maze Therapeutics for a rare disease drug candidate.
December 11, 2023
The agency released two guidance documents on the interim policy on compounding using bulk drug substances for both outsourcing and non-outsourcing facilities.
December 02, 2023
FDA and industry face unprecedented political and policy challenges.
November 30, 2023
Exagamglogene autotemcel seen as synechdoche.
November 20, 2023
Consent decrees were issued against Evig LLC, of St. George, Utah, and Premium Production LLC, of St. George, Utah, for unapproved dietary supplements.
The US District Court for the District of Arizona entered into consent decree against Smart Women’s Choice and its CEO to stop the company from distributing unapproved contraceptive drugs.
November 14, 2023
Adzynma provides a replacement for low levels of the ADAMTS13 enzyme in patients with congenital thrombotic thrombocytopenic purpura.
November 13, 2023
Recommended medicines include treatments for generalized myasthenia gravis, glioma, neovascular age-related macular degeneration, and more.
November 09, 2023
The document includes recommendations for the reporting and implementation of changes to container closure system components.
November 03, 2023
This is the second biologic approved to treat HS, a painful and reoccurring skin disease.