In a mid-year enforcement update, Arnold Golden Gregory partner Gabriel Scannapieco says FDA and the Department of Justice are increasingly extending ...
A 7/20 opinion article contends that FDA acting commissioner Kyle Diamantas has outlined a broad vision for modernizing FDA by emphasizing innovation,...
China approves more novel oncology drugs than the U.S. between 2020 and 2025, with its annual approval totals surpassing FDAs beginning in 2023, accor...
A new study published in JAMA Health Forum suggests the market for compounded GLP-1 weight-loss drugs remains robust despite the FDA's resumption of e...
FDA accepts for priority review a Dyne Therapeutics BLA for zeleciment rostudirsen for treating individuals with Duchenne muscular dystrophy amenable ...
A Nevada businessman enters guilty plea to importing and distributing misbranded prescription erectile dysfunction drugs from India.
FDA issues an Early Alert warning healthcare providers about a potentially high-risk issue involving certain Baxter Duo-Vent solution sets that could ...
FDA cites Fujifilm Diosynth Biotechnologies USA for significant manufacturing deficiencies at its drug substance facility in Research Triangle Park, N...
