Singer further suggests that Congress could explore forms of international drug reciprocity, allowing Americans to purchase certain drugs over the cou...
FDA issues Disc Medicine a complete response letter for its experimental therapy bitopertin, indicated for treating erythropoietic protoporphyria.
A law firm examines FDAs renewed scrutiny of direct-to-consumer television advertising after issuing seven untitled letters so far in 2026.
As part of FDAs recent implementation of the Quality Management System Regulation, a new risk-based inspection model is set to change medical device o...
PTC Therapeutics withdraws its NDA resubmission for Translarna (ataluren) to treat nonsense mutation Duchenne muscular dystrophy, following feedback f...
Sen. Tom Cotton (R-AR) urges FDA to investigate whether illegal or unregulated Chinese-sourced active pharmaceutical ingredients have entered the U.S....
FDA cites Zydus Lifesciences sterile drug manufacturing facility in Vadodara, India, for significant quality control and aseptic processing deficienci...
Medline recalls (Class 1 device correction) certain Medline homecare beds as a Class I recall, warning that continued use without updated instructions...
