FDA denies all requests in a 2013 petition seeking action against DuraSeals Spinal Sealant.
Courthouse News Service says the Justice Department has asked the 3rd Circuit Court of Appeals to reinstate conspiracy charges against KVK-Tech, a New...
FDA revises its guidance on compounding certain ibuprofen oral suspension products to address ongoing product shortages.
Federal Register notice: FDA determines for patent term extension purposes the regulatory review periods for two drug products Janssens Erleada and A...
Federal Register notice: FDA announces a 3/7 Vaccines and Related Biological Products Advisory Committee meeting to discuss the flu vaccines strain se...
The Senate Judiciary Committee clears five drug-related bills that would prohibit brand manufacturers from blocking/delaying generic drug competition,...
FDA grants full approval to GSKs Jemperli (dostarlimab-gxly) for certain adult patients with mismatch repair deficient (dMMR) recurrent or advanced en...
Federal Register notice: FDA issues an order debarring Hassan Tahsildar for two years from providing services to a person that has an approved or pend...
