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.
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...
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,...
FDA issues an Early Alert warning healthcare providers about a potentially high-risk issue involving certain Baxter Duo-Vent solution sets that could ...
FDA issues a Form-483 to Charles River Laboratories' Endosafe contract testing laboratory in Charleston, SC, over multiple quality system deficiencies...
A new study suggests that direct-to-consumer prescription drug Web sites may better communicate the limitations of FDA accelerated approvals when disc...
